Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021777
Company: TEVA PHARMS INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMRIX CYCLOBENZAPRINE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
AMRIX CYCLOBENZAPRINE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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