اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BIMATOPROST از شرکت APOTEX INC
Abbreviated New Drug Application (ANDA): 090449
Company: APOTEX INC
| 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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090449Orig1s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 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 PHARMS LTD |
| BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 090449 | APOTEX INC |
| 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 INC |
| BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 207601 | SOMERSET THERAPS LLC |
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