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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091281
Company: TWI PHARMS INC

Products on ANDA 091281

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091281

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
10/13/2023	SUPPL-10	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 091281

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	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	091281	TWI PHARMS INC

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