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Last Updated: October 6, 2022

Details for New Drug Application (NDA): 020198


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NDA 020198 describes ADALAT CC, which is a drug marketed by Norwich and is included in one NDA. It is available from one supplier. Additional details are available on the ADALAT CC profile page.

The generic ingredient in ADALAT CC is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 020198
Tradename:ADALAT CC
Applicant:Norwich
Ingredient:nifedipine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020198
Suppliers and Packaging for NDA: 020198
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-0695 50090-0695-0 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-0695-0)
ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-0695 50090-0695-2 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-0695-2)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 21, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 21, 1993TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 21, 1993TE:RLD:Yes

Expired US Patents for NDA 020198

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Norwich ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-003 Apr 21, 1993 See Plans and Pricing See Plans and Pricing
Norwich ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-001 Apr 21, 1993 See Plans and Pricing See Plans and Pricing
Norwich ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-002 Apr 21, 1993 See Plans and Pricing See Plans and Pricing
Norwich ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-002 Apr 21, 1993 See Plans and Pricing See Plans and Pricing
Norwich ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-001 Apr 21, 1993 See Plans and Pricing See Plans and Pricing
Norwich ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-003 Apr 21, 1993 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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