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CARISOPRODOL از شرکت NOSTRUM LABS INC

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CARISOPRODOL از شرکت NOSTRUM LABS INC

Abbreviated New Drug Application (ANDA): 207237

Company: NOSTRUM LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARISOPRODOL CARISOPRODOL 250MG TABLET;ORAL Prescription

AB

No No
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
05/11/2017 ORIG-1 Approval

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
05/01/2020 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

CARISOPRODOL

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

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 081025 FOSUN PHARMA
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 040245 MLV
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Prescription No AA 211789 MLV
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 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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