Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210173
Company: ALEMBIC PHARMS LTD

Products on ANDA 210173

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALOGLIPTIN;METFORMIN HYDROCHLORIDE	ALOGLIPTIN;METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
ALOGLIPTIN;METFORMIN HYDROCHLORIDE	ALOGLIPTIN;METFORMIN HYDROCHLORIDE	12.5MG;1000MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210173

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2018	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210173Orig1s000TALtr.pdf