Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018865
Company: FOUGERA PHARMS INC

Products on NDA 018865

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018865

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/1983	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
01/20/2015	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/12/1996	SUPPL-11	Labeling		Label is not available on this site.
03/07/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/29/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/14/1988	SUPPL-8	Labeling		Label is not available on this site.
10/24/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/23/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/23/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for NDA 018865

BETAMETHASONE VALERATE

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