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. 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-eight 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

Medical Subject Heading (MeSH) Categories for 020198

Calcium Channel Blockers
Tocolytic Agents
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 21, 1993	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 21, 1993	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 21, 1993	TE:		RLD:	Yes

Expired US Patents for NDA 020198

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

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