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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074304
Company: ACTAVIS MID ATLANTIC

Products on ANDA 074304

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 074304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/1995	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
06/09/2020	SUPPL-26	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/09/2020	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
08/05/2016	SUPPL-23	Labeling-Container/Carton Labels		Label is not available on this site.
07/31/2002	SUPPL-13	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
07/31/2002	SUPPL-12	Labeling		Label is not available on this site.
07/31/2002	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/30/2001	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
12/29/2000	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
12/29/2000	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
06/28/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/24/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/04/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074304

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 LTD
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	No	AB	076753	TARO
DIPROLENE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED;TOPICAL	Prescription	Yes	AB	018741	ORGANON

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