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
CLEMASTINE FUMARATE از شرکت L PERRIGO CO
Abbreviated New Drug Application (ANDA): 074512
Company: L PERRIGO CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLEMASTINE FUMARATE | CLEMASTINE FUMARATE | 1.34MG | TABLET;ORAL | Over-the-counter |
None |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/22/1995 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/21/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/23/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/23/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLEMASTINE FUMARATE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 1.34MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CLEMASTINE FUMARATE | CLEMASTINE FUMARATE | 1.34MG | TABLET;ORAL | Over-the-counter | No | 074512 | L PERRIGO CO |
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