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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077761
Company: HIKMA FARMACEUTICA

Products on ANDA 077761

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 077761

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2007	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
01/07/2022	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
11/12/2015	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
02/27/2013	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/26/2010	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/19/2010	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/26/2009	SUPPL-6	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077761

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

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