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
BROMFED-DM از شرکت WOCKHARDT BIO AG
Abbreviated New Drug Application (ANDA): 088811
Company: WOCKHARDT BIO AG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BROMFED-DM | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 06/07/1985 | 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 |
|---|---|---|---|---|---|
| 06/03/2016 | SUPPL-26 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2016 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2016 | SUPPL-18 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/30/2004 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/12/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/04/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/19/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/10/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/05/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
BROMFED-DM
SYRUP;ORAL; 2MG/5ML;10MG/5ML;30MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BROMFED-DM | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 088811 | WOCKHARDT BIO AG |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 203375 | ACELLA |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 210647 | ALKEM LABS LTD |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 203997 | BRECKENRIDGE |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 211170 | EYWA |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 213125 | LANNETT CO INC |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 207676 | MAYNE PHARMA INC |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 205292 | PADAGIS US |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 202955 | RHODES PHARMS |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 205112 | TARO |
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