Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050435
Company: PFIZER

Products on NDA 050435

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GEOCILLIN	CARBENICILLIN INDANYL SODIUM	EQ 382MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050435

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/1972	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2008	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050435s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050435s009ltr.pdf
12/23/2004	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50435s008ltr.pdf
11/15/1999	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/17/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/13/1991	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 050435

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2008	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050435s009lbl.pdf