Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212628
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOBRAMYCIN | TOBRAMYCIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
03/09/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/13/2021 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
TOBRAMYCIN
SOLUTION/DROPS;OPHTHALMIC; 0.3%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN | TOBRAMYCIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 211847 | ALEMBIC |
TOBRAMYCIN | TOBRAMYCIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 064052 | BAUSCH AND LOMB |
TOBRAMYCIN | TOBRAMYCIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 065026 | CHARTWELL RX |
TOBRAMYCIN | TOBRAMYCIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 212628 | GLAND PHARMA LTD |
TOBRAMYCIN | TOBRAMYCIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 207444 | SOMERSET THERAPS LLC |
TOBREX | TOBRAMYCIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 062535 | SANDOZ |