Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081025
Company: WANBANG BIOPHARMS
Company: WANBANG BIOPHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 04/13/1989 | 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 |
|---|---|---|---|---|---|
| 03/25/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/2002 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/25/2002 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 03/25/2002 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/18/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/30/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1991 | 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 | 040245 | CHARTWELL RX |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 211789 | MLV |
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 090988 | NATCO |
| 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 | 081025 | WANBANG BIOPHARMS |
| 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 |