Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075160
Company: HOSPIRA

Products on ANDA 075160

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075160

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75160ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75160_Metoprolol%20Tartrate.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2021	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
12/30/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
02/27/2013	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/11/2010	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/04/2008	SUPPL-12	Labeling		Label is not available on this site.
04/28/2008	SUPPL-10	Labeling		Label is not available on this site.
05/15/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/15/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/2002	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/17/2001	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.