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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021777
Company: TEVA PHARMS INTL

Products on NDA 021777

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021777

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2007	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021777lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021777s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021777s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021777s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021777Orig1s017ltr.pdf
05/25/2016	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021777s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021777Orig1s014ltr.pdf
03/24/2016	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/11/2013	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021777Orig1s012ltr.pdf
06/07/2013	SUPPL-9	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777Orig1s006s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021777s006,s009ltr.pdf
06/07/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777s006s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021777Orig1s006,s009ltr.pdf
03/24/2008	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021777s003ltr.pdf

Labels for NDA 021777

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021777s017lbl.pdf
05/25/2016	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021777s014lbl.pdf
06/07/2013	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777Orig1s006s009lbl.pdf
06/07/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777s006s009lbl.pdf
04/11/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777s012lbl.pdf
02/01/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021777lbl.pdf

Therapeutic Equivalents for NDA 021777

AMRIX

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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