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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018642
Company: COSETTE

Products on NDA 018642

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018642

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/1983	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
11/22/2016	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
08/30/2001	SUPPL-22	Manufacturing (CMC)-Facility		Label is not available on this site.
07/07/2000	SUPPL-21	Manufacturing (CMC)-Facility		Label is not available on this site.
01/12/2000	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
06/13/1996	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/14/1995	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
05/04/1995	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/04/1995	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/09/1994	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/09/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/09/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/01/1993	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/30/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/30/1992	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/21/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/15/1988	SUPPL-4	Labeling		Label is not available on this site.
09/10/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for NDA 018642

BETA-VAL

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
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	TARO
VALNAC	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM;TOPICAL	Prescription	No	AB	070050	ACTAVIS MID ATLANTIC

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