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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 019478


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NDA 019478 describes ADALAT, which is a drug marketed by Bayer Pharms and Norwich and is included in two NDAs. Additional details are available on the ADALAT profile page.

The generic ingredient in ADALAT is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 019478
Tradename:ADALAT
Applicant:Bayer Pharms
Ingredient:nifedipine
Patents:0
Medical Subject Heading (MeSH) Categories for 019478

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG
Approval Date:Nov 27, 1985TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength20MG
Approval Date:Sep 17, 1986TE:RLD:No

Expired US Patents for NDA 019478

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Pharms ADALAT nifedipine CAPSULE;ORAL 019478-001 Nov 27, 1985 ⤷  Sign Up ⤷  Sign Up
Bayer Pharms ADALAT nifedipine CAPSULE;ORAL 019478-002 Sep 17, 1986 ⤷  Sign Up ⤷  Sign Up
Bayer Pharms ADALAT nifedipine CAPSULE;ORAL 019478-002 Sep 17, 1986 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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