Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050567
Company: ALLERGAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POLYTRIM POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes 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
10/20/1988 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/19/2003 SUPPL-22 Labeling

Label is not available on this site.
04/12/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
12/04/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
04/12/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
12/18/2000 SUPPL-16 Labeling

Label is not available on this site.
12/05/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
10/02/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
02/04/1998 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
12/02/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
05/19/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
06/23/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
12/31/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
07/03/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
08/03/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
12/02/1996 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
04/17/1993 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/08/1992 SUPPL-3 Labeling

Label is not available on this site.
07/02/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

POLYTRIM

SOLUTION/DROPS;OPHTHALMIC; 10,000 UNITS/ML;EQ 1MG BASE/ML
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POLYTRIM POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 050567 ALLERGAN
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS;OPHTHALMIC Prescription No AT 065006 AKORN
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS;OPHTHALMIC Prescription No AT 064120 BAUSCH AND LOMB
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS;OPHTHALMIC Prescription No AT 064211 SANDOZ INC

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