Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090449
Company: APOTEX
Company: APOTEX
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 |
---|---|---|---|---|---|---|---|
07/20/2015 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090449Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090449Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/01/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
02/13/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
11/20/2018 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/20/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090449Orig1s000lbl.pdf |
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 |