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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019137
Company: FOUGERA PHARMS

Products on NDA 019137

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019137

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/1984	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
09/04/2014	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/05/1997	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/07/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/17/1995	SUPPL-10	Labeling		Label is not available on this site.
10/31/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/31/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/31/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/06/1987	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/20/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/18/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/28/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for NDA 019137

BETAMETHASONE DIPROPIONATE

CREAM;TOPICAL; EQ 0.05% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	No	AB	070885	ACTAVIS MID ATLANTIC
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	No	AB	210217	COSETTE
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	Yes	AB	019137	FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	No	AB	073552	TARO
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM;TOPICAL	Prescription	No	AB	208885	ZYDUS PHARMS

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