Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080660
Company: MIZA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCUSULF-10 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Discontinued None No No
OCUSULF-30 SULFACETAMIDE SODIUM 30% SOLUTION/DROPS;OPHTHALMIC 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
08/24/1972 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
02/13/1996 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/07/1996 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

03/07/1996 SUPPL-45 Labeling

Label is not available on this site.

05/06/1993 SUPPL-44 Labeling

Label is not available on this site.

07/07/1992 SUPPL-43 Labeling

Label is not available on this site.

07/07/1992 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

04/04/1990 SUPPL-41 Labeling

Label is not available on this site.

06/19/1985 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/20/1985 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/13/1984 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/19/1985 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

02/07/1984 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/19/1985 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/15/1982 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

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