Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064211
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML 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
04/13/1998 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
12/23/2002 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/01/2002 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/13/2002 SUPPL-7 Labeling

Label is not available on this site.

04/19/2002 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/05/2001 SUPPL-5 Labeling

Label is not available on this site.

04/07/2000 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/15/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/26/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1999 SUPPL-1 Labeling

Label is not available on this site.

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE

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 INC
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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