Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201894
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
12/01/2014 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/03/2022 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/03/2022 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/10/2018 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
BIMATOPROST
SOLUTION/DROPS;TOPICAL; 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;TOPICAL | Prescription | No | AT | 210515 | ALEMBIC |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;TOPICAL | Prescription | No | AT | 201894 | APOTEX |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;TOPICAL | Prescription | No | AT | 202719 | SANDOZ |
LATISSE | BIMATOPROST | 0.03% | SOLUTION/DROPS;TOPICAL | Prescription | Yes | AT | 022369 | ABBVIE |