Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080028
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BLEPH-10 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Prescription AT No Yes
BLEPH-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
05/25/1971 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
11/15/2002 SUPPL-49 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/03/2002 SUPPL-48 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/15/2001 SUPPL-47 Manufacturing (CMC)-Facility

Label is not available on this site.

08/07/2001 SUPPL-45 Manufacturing (CMC)-Facility

Label is not available on this site.

02/13/2001 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/2000 SUPPL-43 Manufacturing (CMC)-Facility

Label is not available on this site.

09/15/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/14/1997 SUPPL-41 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/14/1997 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/14/1994 SUPPL-39 Labeling

Label is not available on this site.

09/27/1994 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/29/1993 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/27/1993 SUPPL-36 Labeling

Label is not available on this site.

12/12/1991 SUPPL-35 Labeling

Label is not available on this site.

05/02/1989 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/12/1991 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/12/1991 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/12/1991 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/12/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/12/1991 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/29/1988 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/27/1991 SUPPL-26 Labeling

Label is not available on this site.

10/24/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/24/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/05/1983 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/16/1982 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/22/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/28/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/28/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

BLEPH-10

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

BLEPH-30

There are no Therapeutic Equivalents.

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