Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011792
Company: MYLAN SPECIALITY LP
Company: MYLAN SPECIALITY LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOMA | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | AA | Yes | No |
| SOMA | CARISOPRODOL | 250MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
| SOMA | CARISOPRODOL | 250MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/09/1959 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/04/2019 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011792s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/011792Orig1s050ltr.pdf | |
| 08/22/2018 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011792s048lbl.pdf | |
| 02/23/2015 | SUPPL-46 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011792Orig1s046ltr.pdf |
| 02/01/2013 | SUPPL-45 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011792s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/011792Orig1s045ltr.pdf | |
| 11/17/2009 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011792s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011792s043ltr.pdf | |
| 11/06/2009 | SUPPL-42 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/13/2007 | SUPPL-41 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011792s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011792s041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf | |
| 12/29/1999 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/07/2006 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011792s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011792s035LTR.pdf | |
| 10/25/1993 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1994 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1987 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/01/1987 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1986 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/30/1986 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/27/1987 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/19/1983 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1983 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1983 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1979 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1979 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/1979 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/20/1975 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/08/1974 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/19/1974 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/13/1974 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/04/2019 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011792s050lbl.pdf | |
| 08/22/2018 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011792s048lbl.pdf | |
| 02/01/2013 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011792s045lbl.pdf | |
| 02/01/2013 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011792s045lbl.pdf | |
| 11/17/2009 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011792s043lbl.pdf | |
| 09/13/2007 | SUPPL-41 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011792s041lbl.pdf | |
| 06/07/2006 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011792s035lbl.pdf |
SOMA
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 |
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 |