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): 077360
Company: SANDOZ

Products on ANDA 077360

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077360

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/02/2007	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
08/13/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/22/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/06/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/10/2009	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/18/2008	SUPPL-3	Labeling		Label is not available on this site.
07/21/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077360

METOPROLOL TARTRATE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078950	BAXTER HLTHCARE CORP
METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091045	FRESENIUS KABI USA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204205	GLAND PHARMA LTD
METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076495	HIKMA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077761	HIKMA FARMACEUTICA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078085	HOSPIRA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077360	SANDOZ

Top