Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011792
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 No 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
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
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 040124 HIKMA INTL PHARMS
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 040823 INGENUS PHARMS NJ
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 090988 NATCO PHARMA LTD
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 205085 ORIENT PHARMA CO LTD
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 203374 SCIEGEN PHARMS INC
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 205513 STRIDES PHARMA
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 089346 SUN PHARM INDS
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 040755 SUN PHARM INDS LTD
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 040245 VINTAGE PHARMS
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 205513 STRIDES PHARMA
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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