Application Information

This drug has been submitted to the FDA under the reference 019192/001.

Names and composition

"TRIPHASIL-21" is the commercial name of a drug composed of ETHINYL ESTRADIOL and LEVONORGESTREL.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
019192/001 TRIPHASIL-21 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
018668/001 NORDETTE-21 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.03MG and 0.15MG
018782/001 NORDETTE-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG and 0.15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019190/001 TRIPHASIL-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019192/001 TRIPHASIL-21 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020683/001 ALESSE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.02MG and 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020683/002 ALESSE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020860/001 LEVLITE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.02MG and 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020860/002 LEVLITE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020946/001 PREVEN EMERGENCY CONTRACEPTIVE KIT ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.05MG and 0.25MG
021544/001 SEASONALE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG and 0.15MG
021840/001 SEASONIQUE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG,0.01MG and 0.15MG,N per A
021864/001 LYBREL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG and 0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
022262/001 LOSEASONIQUE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG,0.01MG and 0.1MG,N per A
073592/001 LEVORA 0.15/30-21 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.03MG and 0.15MG
073594/001 LEVORA 0.15/30-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG and 0.15MG
074538/001 TRIVORA-21 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG
074538/002 TRIVORA-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG
075796/001 AVIANE-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
075796/002 AVIANE-21 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.02MG and 0.1MG
075803/001 LESSINA-21 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.02MG and 0.1MG
075803/002 LESSINA-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
075809/001 ENPRESSE-21 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG
075809/002 ENPRESSE-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG
075862/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.02MG and 0.1MG
075862/002 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
075866/001 PORTIA-21 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-21 0.03MG and 0.15MG
075866/002 PORTIA-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG and 0.15MG
076625/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
077099/001 ORSYTHIA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
077101/001 QUASENSE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG and 0.15MG
077502/001 MYZILRA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG
077681/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
078834/001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG,0.01MG and 0.15MG,N per A
079064/001 INTROVALE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG and 0.15MG
079102/001 ALTAVERA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG and 0.15MG
079218/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG and 0.09MG
090716/001 SETLAKIN ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG and 0.15MG
090719/001 LEVONEST ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG
090721/001 FALMINA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
091408/001 KURVELO ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG and 0.15MG
091425/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
091440/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG and 0.15MG
091452/001 MARLISSA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG and 0.15MG
091467/001 DAYSEE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG,0.01MG and 0.15MG,N per A
091663/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG and 0.15MG
091674/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG,0.01MG and 0.1MG,N per A
091690/001 ETHINYL ESTRADIOL AND LEVONORGESTREL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG,0.01MG and 0.15MG,N per A
200245/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
200248/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG
200407/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG,0.01MG and 0.1MG,N per A
200490/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG and 0.15MG
200492/001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG,0.01MG and 0.15MG,N per A
200493/001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG,0.01MG and 0.1MG,N per A
201088/001 VIENVA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
201095/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG and 0.15MG
201108/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
202247/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG
202507/001 ELIFEMME ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG,0.04MG,0.03MG and 0.05MG,0.075MG,0.125MG
202791/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG and 0.09MG
203163/001 ASHLYNA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG,0.01MG and 0.15MG,N per A
203164/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG and 0.15MG
203871/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG and 0.15MG
203872/001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG,0.01MG and 0.15MG,N per A
204061/001 QUARTETTE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG,0.15MG and 0.025MG,0.15MG and 0.03MG,0.15MG and 0.01MG,N per A
205943/001 FAYOSIM ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG,0.15MG and 0.025MG,0.15MG and 0.03MG,0.15MG and 0.01MG,N per A
206201/001 ETHINYL ESTRADIOL; LEVONORGESTREL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG,0.15MG and 0.025MG,0.15MG and 0.03MG,0.15MG and 0.01MG,N per A
206851/001 SIMPESSE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.03MG,0.01MG and 0.15MG,N per A
206852/001 LO SIMPESSE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL 0.02MG,0.01MG and 0.01MG,N per A
206866/001 AYUNA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.03MG and 0.15MG
206886/001 AFIRMELLE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET/ORAL-28 0.02MG and 0.1MG

Ask a doctor

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Answered questions

Stopped taking Triphasil 21 for a week, question!?
If I completed the whole pack of my pills, the last pill I took was on a Friday night 31st Oct, which was a red tablet. then I stopped for a week (without taking any pills that whole week) but started again a week later with the brown pill the following Saturday night 8th November. So basically for 7 whole days I... Asked by Sharron Maresca 1 year ago.

If I completed the whole pack of my pills, the last pill I took was on a Friday night 31st Oct, which was a red tablet. then I stopped for a week (without taking any pills that whole week) but started again a week later with the brown pill the following Saturday night 8th November. So basically for 7 whole days I didnt take any pills and I had unprotected sex with my husband during that week and the week after. My last period was 28th Oct and expected my next on the 25th November, which I didnt get and my periods are very regular. Have I completly messed up my cycle cors I havnt gotten my period yet and its the 1st of December now? I'v been having stomach cramps like period pains, alot of lower back pain, nausea, increased appetite, tiredness and very moody. Is all of that normal or does it mean something else? Isnt it normal to miss your period if you miss pills and mess up your cycle? And about the symtoms, my breasts are not sore though usually thats the biggest sign, isnt it? Answered by Brittney Guenthur 1 year ago.

By stopping your pill and restarting later can mess up your cycle. There are a coupld things you are not clear about but you should have started you period in the week you didnt take the pill. If you had your period early then you body is probably confused and that is why you did not start as expected on the 25th Nov. Also you don't mention if you were taking the placebos (sugar pills) at the moment or if you are actually taking the proper pill. If it is the pill then you will not have your period now. However if you did not take the placebos then you will have no porblem. Your symptoms could be of pregnancy but it is unusual to fall pregnant so soon after not taking the pill but not impossible. Check that you are on the placebo parts of the pill and if not then that will explain why you have not started. If youare then take a pregnancy test to confirm. Answered by Zora Stolarz 1 year ago.


Anyone stopped taking the pill for a week then your period arrived a week late......?
I'm on Triphasil 21, i finished the whole pack last month (including the red tablets) then stopped taking them for a full 7 days, then started again with the brown tablets.My period was then a week late aswell (is that normal?) but it was much lighter than usual (wasnt like spotting tho). Red in toilet and when... Asked by Wilmer Helfen 1 year ago.

I'm on Triphasil 21, i finished the whole pack last month (including the red tablets) then stopped taking them for a full 7 days, then started again with the brown tablets. My period was then a week late aswell (is that normal?) but it was much lighter than usual (wasnt like spotting tho). Red in toilet and when wiped, yesterday would be the last day of my period but had pinkish discharge and tiny spotting, then again it could just be the end of my period. What u think? Do apologiz if TMI I'm so bloated at the moment, i can hardly breath (maybe i ate alot)... lol Answered by Rueben Ledger 1 year ago.

If you started the pills a week later than your period would be a week later because you have a 28 day cycle so it would be 28 days from when you started taking the pills so if you start a week later you'd end a week later. Answered by Kimberely Eustice 1 year ago.


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