Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064134
Company: BAUSCH AND LOMB
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 |
---|---|---|---|---|---|
07/21/2023 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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07/21/2023 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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11/06/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
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02/05/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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11/27/2001 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/07/2001 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/27/2000 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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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 | 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 |