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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075373
Company: FOUGERA PHARMS

Products on ANDA 075373

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075373

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/1999	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75373ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-373_Betamethasone%20Dipropionate.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
06/09/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/12/2016	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/12/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075373

BETAMETHASONE DIPROPIONATE

OINTMENT, 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	OINTMENT, AUGMENTED;TOPICAL	Prescription	No	AB	074304	ACTAVIS MID ATLANTIC
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	No	AB	218289	AUROBINDO PHARMA LTD
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	No	AB	075373	FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	No	AB	209106	LUPIN
DIPROLENE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	Yes	AB	018741	ORGANON

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