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): 064048
Company: BAUSCH AND LOMB INC

Products on ANDA 064048

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064048

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/1994	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
11/27/2001	SUPPL-14	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/29/2001	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/07/2001	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/05/2000	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/27/2000	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/15/2000	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		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.
11/19/1998	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/04/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/14/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/26/1996	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/09/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064048

GENTAMICIN SULFATE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	064048	BAUSCH AND LOMB INC
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	062196	SANDOZ

Top