An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076756
Company: NOSTRUM PHARMS LLC

Products on ANDA 076756

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076756

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/2006	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
11/05/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/05/2019	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/12/2011	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076756

METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	209303	ALIGNSCIENCE PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	206145	ALKEM LABS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	079118	AUROBINDO PHARMA LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	078321	CSPC OUYI
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	209313	GRANULES
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	218673	HARMAN FINOCHEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	201991	INVENTIA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	217631	LAURUS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	206955	MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	090295	MARKSANS PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	076756	NOSTRUM PHARMS LLC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	202306	PLATINUM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	208880	PRINSTON INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	207427	REGCON HOLDINGS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	076873	SANDOZ
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	076269	TEVA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	213359	UNICHEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	211052	YICHANG HUMANWELL
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	077060	ZYDUS LIFESCIENCES

TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076869	ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206145	ALKEM LABS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	079118	AUROBINDO PHARMA LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078321	CSPC OUYI
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209313	GRANULES
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	218673	HARMAN FINOCHEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217631	LAURUS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206955	MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090295	MARKSANS PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076756	NOSTRUM PHARMS LLC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202306	PLATINUM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208880	PRINSTON INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207427	REGCON HOLDINGS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076864	TEVA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213359	UNICHEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211052	YICHANG HUMANWELL
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077078	ZYDUS LIFESCIENCES

Top