Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074421
Company: PLIVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG 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
09/29/1995 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-33 Labeling-Package Insert

Label is not available on this site.

04/02/2013 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

03/16/2010 SUPPL-21 Labeling

Label is not available on this site.

05/29/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

03/16/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2000 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/07/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

07/01/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CYCLOBENZAPRINE HYDROCHLORIDE

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 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 078218 ORIT LABS LLC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077209 OXFORD PHARMS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 074421 PLIVA
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

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