Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071012
Company: ACTAVIS MID ATLANTIC

Products on ANDA 071012

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071012

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/1987	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
03/30/2015	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
01/14/2003	SUPPL-14	Labeling		Label is not available on this site.
05/30/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
12/29/2000	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
06/28/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/07/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/07/1995	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/07/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/29/1993	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/11/1989	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/06/1989	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071012

BETAMETHASONE DIPROPIONATE

OINTMENT;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;TOPICAL	Prescription	No	AB	071012	ACTAVIS MID ATLANTIC
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT;TOPICAL	Prescription	Yes	AB	019141	FOUGERA PHARMS INC
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT;TOPICAL	Prescription	No	AB	215847	PADAGIS ISRAEL
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT;TOPICAL	Prescription	No	AB	074271	TARO
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT;TOPICAL	Prescription	No	AB	215186	TASMAN PHARMA
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT;TOPICAL	Prescription	No	AB	214048	ZYDUS LIFESCIENCES