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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075269
Company: VALEANT PHARMS NORTH

Products on ANDA 075269

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075269

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/2000	ORIG-1	Approval			Letter (PDF) Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75269ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75269ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075269.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2012	SUPPL-10	Labeling		Label is not available on this site.
12/16/2002	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/15/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
12/28/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
07/15/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
02/14/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 075269

NIFEDIPINE

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	213361	AUROBINDO PHARMA
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	202987	NOVAST LABS
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	075269	VALEANT PHARMS NORTH
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	210184	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	213361	AUROBINDO PHARMA
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	202987	NOVAST LABS
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	075269	VALEANT PHARMS NORTH
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	210184	ZYDUS PHARMS

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