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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207314
Company: MACLEODS PHARMS LTD

Products on ANDA 207314

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 207314

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207314

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	207314	MACLEODS PHARMS LTD
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214732	NOVAST LABS
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	207314	MACLEODS PHARMS LTD
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214732	NOVAST LABS
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	091281	TWI PHARMS INC

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