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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070275
Company: FOUGERA PHARMS INC

Products on ANDA 070275

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070275

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/1985	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
08/17/1995	SUPPL-10	Labeling		Label is not available on this site.
01/06/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
11/03/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/03/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/03/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/29/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/21/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/28/1986	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 ANDA 070275

BETAMETHASONE DIPROPIONATE

LOTION;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	LOTION;TOPICAL	Prescription	No	AB	071467	COSETTE
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION;TOPICAL	Prescription	No	AB	070275	FOUGERA PHARMS INC
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION;TOPICAL	Prescription	No	AB	072538	PADAGIS US

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