An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 064211
Company: SANDOZ

Products on ANDA 064211

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064211

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
05/18/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 064211

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
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	065006	EPIC PHARMA LLC
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

Top