Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022141
Company: MYLAN LABS LTD

Products on NDA 022141

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIMDUO	LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	300MG;300MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022141

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2018	ORIG-1	Approval	Type 4 - New Combination	PRIORITY	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022141s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/022141Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2018	SUPPL-24		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022141Orig1s024ltr.pdf

Labels for NDA 022141

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022141s000lbl.pdf