Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074305
Company: SANDOZ

Products on ANDA 074305

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLIPIZIDE	GLIPIZIDE	5MG	TABLET;ORAL	Discontinued	None	No	No
GLIPIZIDE	GLIPIZIDE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074305

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/1995	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
04/11/2017	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
04/11/2017	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
07/26/2013	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
05/19/2009	SUPPL-23	Labeling		Label is not available on this site.
03/25/2002	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
04/19/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
08/09/2001	SUPPL-10	Labeling		Label is not available on this site.
09/21/2001	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
12/05/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
12/13/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/2000	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
12/17/1999	SUPPL-5	Labeling		Label is not available on this site.
02/01/1999	SUPPL-3	Labeling		Label is not available on this site.
02/01/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/22/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.