Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089560
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
10/18/1988 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
05/20/2003 SUPPL-19 Labeling

Label is not available on this site.

01/24/2003 SUPPL-18 Labeling

Label is not available on this site.

02/19/1999 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/16/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/08/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/17/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/08/1989 SUPPL-3 Labeling

Label is not available on this site.

05/09/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/09/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

SULFACETAMIDE SODIUM

SOLUTION/DROPS;OPHTHALMIC; 10%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BLEPH-10 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 080028 ALLERGAN
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040215 AKORN
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040066 BAUSCH AND LOMB
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 089560 SANDOZ INC

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