Application Information

This drug has been submitted to the FDA under the reference 072409/001.

Names and composition

"NIFEDIPINE" is the commercial name of a drug composed of NIFEDIPINE.
It belongs to the class Calcium-channel blockers and is used in Hypertension (Cardiovascular System)

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
072409/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
072556/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 20MG
072579/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
072651/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
072781/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
073250/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
073421/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 20MG
074045/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 20MG
075108/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
075269/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
075269/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
075289/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
075289/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
075414/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ ORAL 90MG
075414/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
076070/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
077127/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
077127/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
077410/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
077899/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
077899/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
077899/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
090602/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
090602/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
090602/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
090649/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
090649/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
090649/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
201071/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
201071/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
201071/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
202644/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
202644/002 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 20MG
202987/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
202987/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
202987/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
203126/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
203126/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
203126/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
018482/001 PROCARDIA NIFEDIPINE CAPSULE/ORAL 10MG
018482/002 PROCARDIA NIFEDIPINE CAPSULE/ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019478/001 ADALAT NIFEDIPINE CAPSULE/ORAL 10MG
019478/002 ADALAT NIFEDIPINE CAPSULE/ORAL 20MG
019684/001 PROCARDIA XL NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
019684/002 PROCARDIA XL NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
019684/003 PROCARDIA XL NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
020198/001 ADALAT CC NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
020198/002 ADALAT CC NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
020198/003 ADALAT CC NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
072409/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
072556/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 20MG
072579/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
072651/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
072781/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
073250/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
073421/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 20MG
074045/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 20MG
075108/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
075128/001 AFEDITAB CR NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
075269/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
075269/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
075289/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
075289/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
075414/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ ORAL 90MG
075414/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
075659/001 AFEDITAB CR NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
076070/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
077127/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
077127/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
077410/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
077899/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
077899/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
077899/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
090602/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
090602/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
090602/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
090649/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
090649/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
090649/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
201071/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
201071/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
201071/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
202644/001 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 10MG
202644/002 NIFEDIPINE NIFEDIPINE CAPSULE/ORAL 20MG
202987/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
202987/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
202987/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG
203126/001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
203126/002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 60MG
203126/003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE/ORAL 90MG

Manufacturers

Manufacturer name
Bayer plc
Chiesi Ltd
Ranbaxy (UK) Ltd
UCB Pharma Ltd
Concordia International
Dexcel Pharma Ltd
Genus Pharmaceuticals
Winthrop Pharmaceuticals

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