Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081025
Company: FOSUN PHARMA
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 040245 ALLIED
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 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 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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