Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091281
Company: TWI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;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
01/31/2013 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
03/13/2018 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/06/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

CYCLOBENZAPRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMRIX CYCLOBENZAPRINE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021777 TEVA PHARMS INTL
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206703 APOTEX
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091281 TWI PHARMS INC

CAPSULE, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMRIX CYCLOBENZAPRINE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021777 TEVA PHARMS INTL
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206703 APOTEX
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091281 TWI PHARMS INC

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