Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206952
Company: ACTAVIS LABS FL INC

Products on ANDA 206952

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	10MG	CAPSULE, EXTENDED RELEASE; ORAL	None (Tentative Approval)	None	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	20MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	30MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	50MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206952

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2017	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.