Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212473
Company: ALEMBIC

Products on ANDA 212473

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212473

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/23/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212473

DESONIDE

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	212473	ALEMBIC
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	210998	ENCUBE ETHICALS
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	075751	FOUGERA PHARMS
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	209996	GLENMARK PHARMS LTD
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	Yes	AB	017426	PADAGIS US
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	074254	TARO
DESOWEN	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	071425	GALDERMA LABS LP