Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207601
Company: SOMERSET THERAPS LLC
Company: SOMERSET THERAPS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BIMATOPROST | BIMATOPROST | 0.03% | 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 |
---|---|---|---|---|---|---|---|
06/19/2019 | 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 |
---|---|---|---|---|---|
12/20/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
12/20/2022 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/20/2022 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
BIMATOPROST
SOLUTION/DROPS;OPHTHALMIC; 0.03%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 210263 | ALEMBIC |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 090449 | APOTEX |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 205537 | EUGIA PHARMA |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 210126 | GLAND PHARMA LTD |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 203991 | LUPIN LTD |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 202505 | MICRO LABS |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 202565 | SANDOZ |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 207601 | SOMERSET THERAPS LLC |