Drugs@FDA: FDA Approved Drug Products

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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
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 040245 ALLIED
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 090988 NATCO PHARMA LTD
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 203374 SCIEGEN PHARMS INC
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 205513 STRIDES PHARMA
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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