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
CARISOPRODOL از شرکت AUROBINDO PHARMA
Abbreviated New Drug Application (ANDA): 040792
Company: AUROBINDO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription |
AA |
No | No |
| CARISOPRODOL | CARISOPRODOL | 250MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 08/06/2009 | 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 |
|---|---|---|---|---|---|
| 11/13/2018 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/26/2018 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2013 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/03/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CARISOPRODOL
TABLET;ORAL; 350MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 040576 | ACCELRX LABS |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 040792 | AUROBINDO PHARMA |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 081025 | FOSUN PHARMA |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 040245 | MLV |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 211789 | MLV |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 090988 | NATCO PHARMA LTD |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 207237 | NOSTRUM LABS INC |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 040823 | NOVAST LABS |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 205085 | ORIENT PHARMA CO LTD |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 040188 | OXFORD PHARMS |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 203374 | SCIEGEN PHARMS INC |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 087499 | WATSON LABS |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 205126 | WILSHIRE PHARMS INC |
| SOMA | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | Yes | AA | 011792 | MYLAN SPECIALITY LP |
TABLET;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARISOPRODOL | CARISOPRODOL | 250MG | TABLET;ORAL | Prescription | No | AB | 040792 | AUROBINDO PHARMA |
| CARISOPRODOL | CARISOPRODOL | 250MG | TABLET;ORAL | Prescription | No | AB | 207237 | NOSTRUM LABS INC |
| CARISOPRODOL | CARISOPRODOL | 250MG | TABLET;ORAL | Prescription | No | AB | 205126 | WILSHIRE PHARMS INC |
| SOMA | CARISOPRODOL | 250MG | TABLET;ORAL | Prescription | Yes | AB | 011792 | MYLAN SPECIALITY LP |
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