Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080029
Company: PERRIGO CO TENNESSEE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% OINTMENT;OPHTHALMIC Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/22/1971 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
03/07/1996 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/03/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/03/1995 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

01/19/1995 SUPPL-32 Labeling

Label is not available on this site.

03/13/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/14/1993 SUPPL-30 Labeling

Label is not available on this site.

05/02/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/19/1989 SUPPL-27 Labeling

Label is not available on this site.

03/25/1988 SUPPL-26 Labeling

Label is not available on this site.

08/01/1983 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

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