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
BROMPHENIRAMINE MALEATE از شرکت WATSON LABS
Abbreviated New Drug Application (ANDA): 083821
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BROMPHENIRAMINE MALEATE | BROMPHENIRAMINE MALEATE | 10MG/ML | INJECTABLE;INJECTION | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 05/20/1976 | 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 |
|---|---|---|---|---|---|
| 02/19/1999 | SUPPL-24 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-22 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/04/1996 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/11/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/23/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/15/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/31/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/22/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/05/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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