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): 064134
Company: BAUSCH AND LOMB INC

Products on ANDA 064134

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN AND DEXAMETHASONE	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064134

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-134_Tobramycin%20and%20Dexamethasone_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64134LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-134_Tobramycin.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/2023	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
07/21/2023	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
11/06/2008	SUPPL-9	Labeling		Label is not available on this site.
02/05/2002	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
11/27/2001	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/07/2001	SUPPL-4	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/27/2000	SUPPL-3	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/21/2000	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
07/20/2000	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Labels for ANDA 064134

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/27/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-134_Tobramycin%20and%20Dexamethasone_prntlbl.pdf

Therapeutic Equivalents for ANDA 064134

TOBRAMYCIN AND DEXAMETHASONE

SUSPENSION/DROPS;OPHTHALMIC; 0.1%;0.3%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOBRADEX	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	Yes	AB	050592	SANDOZ
TOBRAMYCIN AND DEXAMETHASONE	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	064134	BAUSCH AND LOMB INC
TOBRAMYCIN AND DEXAMETHASONE	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	212715	PADAGIS US

Top