Drugs@FDA: FDA Approved Drug Products

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

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

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 NOVARTIS
TOBRAMYCIN AND DEXAMETHASONE DEXAMETHASONE; TOBRAMYCIN 0.1%;0.3% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 064134 BAUSCH AND LOMB

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