Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202894
Company: GLENMARK PHARMS

Products on ANDA 202894

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202894

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/2015	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
05/29/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/29/2020	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/13/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202894

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

CREAM;TOPICAL; EQ 0.05% BASE;1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	076002	ACTAVIS MID ATLANTIC
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	075502	FOUGERA PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	202894	GLENMARK PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	075673	TARO