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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064134
Company: BAUSCH AND LOMB

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.cfm

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
TOBRAMYCIN AND DEXAMETHASONE	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	212715	PADAGIS US

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