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Details for New Drug Application (NDA): 020198

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NDA 020198 describes ADALAT CC, which is a drug marketed by Alvogen and is included in one NDA. It is available from six suppliers. 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. Fifty-one suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for NDA: 020198

Tradename:
ADALAT CC
Applicant:
Alvogen
Ingredient:
nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020198

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

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 Alvogen, Inc. 47781-368 47781-368-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (47781-368-01)
ADALAT CC
nifedipine
TABLET, EXTENDED RELEASE;ORAL 020198 NDA AUTHORIZED GENERIC Alvogen, Inc. 47781-369 47781-369-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (47781-369-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Apr 21, 1993TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Apr 21, 1993TE:AB1RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Apr 21, 1993TE:AB1RLD:Yes

Expired Orange Book Patents for NDA: 020198

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen
ADALAT CC
nifedipine
TABLET, EXTENDED RELEASE;ORAL020198-001Apr 21, 19934,892,741► subscribe
Alvogen
ADALAT CC
nifedipine
TABLET, EXTENDED RELEASE;ORAL020198-002Apr 21, 19935,264,446► subscribe
Alvogen
ADALAT CC
nifedipine
TABLET, EXTENDED RELEASE;ORAL020198-003Apr 21, 19935,264,446► subscribe
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