Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050435
Company: PFIZER
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
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.

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

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