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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210184
Company: ZYDUS PHARMS

Products on ANDA 210184

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
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210184

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210184

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

TABLET, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	213361	AUROBINDO PHARMA
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	202987	NOVAST LABS
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	076070	VALEANT PHARMS NORTH
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	210184	ZYDUS PHARMS

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