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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050646
Company: GLAXOSMITHKLINE

Products on NDA 050646

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEPTAZ	CEFTAZIDIME	500MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
CEPTAZ	CEFTAZIDIME	1GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
CEPTAZ	CEFTAZIDIME	2GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
CEPTAZ	CEFTAZIDIME	10GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050646

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/1990	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2002	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
02/23/2000	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
03/29/2002	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050646s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf
11/25/1997	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
04/03/1997	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/24/1996	SUPPL-11	Labeling		Label is not available on this site.
06/20/1996	SUPPL-10	Labeling		Label is not available on this site.
06/20/1996	SUPPL-9	Labeling		Label is not available on this site.
01/26/1998	SUPPL-8	Labeling		Label is not available on this site.
08/20/1996	SUPPL-7	Labeling		Label is not available on this site.
09/11/1996	SUPPL-6	Labeling		Label is not available on this site.
10/20/1994	SUPPL-5	Labeling		Label is not available on this site.
09/07/1994	SUPPL-4	Labeling		Label is not available on this site.
08/09/1991	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/10/1992	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
09/09/1992	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 050646

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2002	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050646s014lbl.pdf

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