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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077127
Company: OSMOTICA PHARM US

Products on ANDA 077127

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB2	No	No
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB2	No	No
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077127

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2005	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/11/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077127

NIFEDIPINE

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB2

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	AB2	216896	ALEMBIC
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	216067	ALKEM LABS LTD
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210614	NOVAST LABS
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	077127	OSMOTICA PHARM US
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210838	SPIL
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	203126	TWI PHARMS
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	075289	VALEANT PHARMS NORTH
NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210012	ZYDUS PHARMS
PROCARDIA XL	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB2	019684	PFIZER

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB2

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	AB2	216896	ALEMBIC
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	216067	ALKEM LABS LTD
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210614	NOVAST LABS
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	077127	OSMOTICA PHARM US
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210838	SPIL
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	203126	TWI PHARMS
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	075289	VALEANT PHARMS NORTH
NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210012	ZYDUS PHARMS
PROCARDIA XL	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB2	019684	PFIZER

TABLET, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB2

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	AB2	216896	ALEMBIC
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	216067	ALKEM LABS LTD
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	212016	ELITE PHARM SOLUTION
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210614	NOVAST LABS
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	077127	OSMOTICA PHARM US
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210838	SPIL
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	203126	TWI PHARMS
NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210012	ZYDUS PHARMS
PROCARDIA XL	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB2	019684	PFIZER

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