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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070050
Company: ACTAVIS MID ATLANTIC

Products on ANDA 070050

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALNAC	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070050

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/1984	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/30/2001	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
12/29/2000	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/2000	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
03/14/2000	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
06/28/1996	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/13/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/13/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
09/13/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/13/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/07/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/22/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/22/1995	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/29/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/11/1989	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/13/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070050

VALNAC

CREAM;TOPICAL; EQ 0.1% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETA-VAL	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM;TOPICAL	Prescription	No	AB	018642	COSETTE PHARMS NC
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM;TOPICAL	Prescription	Yes	AB	018861	FOUGERA PHARMS INC
DERMABET	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM;TOPICAL	Prescription	No	AB	072041	SUN PHARMA CANADA
VALNAC	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM;TOPICAL	Prescription	No	AB	070050	ACTAVIS MID ATLANTIC

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