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 WATSON LABS
Abbreviated New Drug Application (ANDA): 087499
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 04/20/1982 | 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 |
|---|---|---|---|---|---|
| 04/27/2020 | SUPPL-58 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2020 | SUPPL-55 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2013 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2010 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 01/25/2010 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 01/29/2009 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-22 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 09/14/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1989 | SUPPL-15 | Bioequivalence |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/01/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1983 | SUPPL-1 | Manufacturing (CMC) |
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 |
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