Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 064120
Company: BAUSCH AND LOMB
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
02/14/1997 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
06/13/2002 SUPPL-16 Labeling

Label is not available on this site.

11/27/2001 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/21/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/30/2001 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/07/2001 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/27/2000 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/11/2000 SUPPL-10 Labeling

Label is not available on this site.

11/17/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/2000 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/18/2000 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/07/1999 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/13/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/05/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/19/1998 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/23/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/23/1998 SUPPL-1 Manufacturing (CMC)

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English