Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076873
Company: SANDOZ

Products on ANDA 076873

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076873

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2004	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
11/08/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/08/2019	SUPPL-8	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
05/07/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076873

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	078596	AMNEAL PHARMS NY
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	207427	BEXIMCO PHARMS USA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	077060	CADILA
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	202306	INTELLIPHARMACEUTICS
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	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	208880	PRINSTON INC
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	077336	SUN PHARM INDS (IN)
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