Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206348
Company: ACTAVIS LABS UT INC

Products on ANDA 206348

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROTIGOTINE	ROTIGOTINE	1MG/24HOURS	SYSTEM; TRANSDERMAL	None (Tentative Approval)	None	No	No
ROTIGOTINE	ROTIGOTINE	2MG/24HOURS	SYSTEM; TRANSDERMAL	None (Tentative Approval)	None	No	No
ROTIGOTINE	ROTIGOTINE	3MG/24HOURS	SYSTEM; TRANSDERMAL	None (Tentative Approval)	None	No	No
ROTIGOTINE	ROTIGOTINE	4MG/24HOURS	SYSTEM; TRANSDERMAL	None (Tentative Approval)	None	No	No
ROTIGOTINE	ROTIGOTINE	6MG/24HOURS	SYSTEM; TRANSDERMAL	None (Tentative Approval)	None	No	No
ROTIGOTINE	ROTIGOTINE	8MG/24HOURS	SYSTEM; TRANSDERMAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206348

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2018	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206348Orig1s000ltr.pdf