Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040124
Company: HIKMA INTL PHARMS
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
01/24/1996 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
06/09/2015 SUPPL-20 Labeling-Container/Carton Labels

Label is not available on this site.

05/27/2011 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

08/02/2010 SUPPL-16 Labeling

Label is not available on this site.

12/31/2007 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/040124s014ltr.pdf
06/12/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/2002 SUPPL-10 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/15/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2000 SUPPL-8 Labeling

Label is not available on this site.

12/04/2000 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2000 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/04/2000 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/01/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/24/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/24/1998 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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