Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075276
Company: FOUGERA PHARMS

Products on ANDA 075276

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075276

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/2003	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/75276_Betamethasone%20Dipropionate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/75276_Betamethasone%20Dipropionate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/075276_betamethasone-dipropionate_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/22/2004	SUPPL-6	Labeling		Label is not available on this site.
06/16/2004	SUPPL-2	Labeling		Label is not available on this site.

Labels for ANDA 075276

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/75276_Betamethasone%20Dipropionate_Prntlbl.pdf

Therapeutic Equivalents for ANDA 075276

BETAMETHASONE DIPROPIONATE

GEL, AUGMENTED;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	GEL, AUGMENTED;TOPICAL	Prescription	No	AB	075276	FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED;TOPICAL	Prescription	No	AB	076508	TARO