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CYCLOBENZAPRINE HYDROCHLORIDE از شرکت JUBILANT CADISTA

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CYCLOBENZAPRINE HYDROCHLORIDE از شرکت JUBILANT CADISTA

Abbreviated New Drug Application (ANDA): 077563

Company: JUBILANT CADISTA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription

AB

No No
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription

AB

No No
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription

AB

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
04/19/2006 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
04/11/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

CYCLOBENZAPRINE HYDROCHLORIDE

TABLET;ORAL; 5MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 071611 ACTAVIS LABS FL INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078218 ALEMBIC LABS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 073541 ANDA REPOSITORY
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078643 AUROBINDO PHARMA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090478 INVAGEN PHARMS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077563 JUBILANT CADISTA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078048 KVK TECH
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 073144 MYLAN PHARMS INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077209 OXFORD PHARMS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077797 PRINSTON INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208170 RUBICON
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078722 SUN PHARM INDS LTD
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 213324 UNICHEM

TABLET;ORAL; 10MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 071611 ACTAVIS LABS FL INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078218 ALEMBIC LABS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 073541 ANDA REPOSITORY
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078643 AUROBINDO PHARMA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090478 INVAGEN PHARMS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077563 JUBILANT CADISTA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078048 KVK TECH
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 073144 MYLAN PHARMS INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077209 OXFORD PHARMS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077797 PRINSTON INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208170 RUBICON
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078722 SUN PHARM INDS LTD
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 213324 UNICHEM

TABLET;ORAL; 7.5MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 071611 ACTAVIS LABS FL INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 078218 ALEMBIC LABS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 077563 JUBILANT CADISTA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 073144 MYLAN PHARMS INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 208170 RUBICON
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 078722 SUN PHARM INDS LTD
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 213324 UNICHEM
بخوانید  CYCLOBENZAPRINE HYDROCHLORIDE از شرکت SUN PHARM INDS LTD
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