Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070069
Company: COSETTE

Products on ANDA 070069

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070069

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/1985	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
08/30/2001	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
06/13/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/13/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/25/1990	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/18/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/14/1988	SUPPL-2	Labeling		Label is not available on this site.
02/14/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070069

BETA-VAL

OINTMENT;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	OINTMENT;TOPICAL	Prescription	No	AB	070069	COSETTE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT;TOPICAL	Prescription	No	AB	070051	ACTAVIS MID ATLANTIC
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT;TOPICAL	Prescription	Yes	AB	018865	FOUGERA PHARMS INC