Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214396
Company: ALEMBIC

Products on ANDA 214396

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214396

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214396

DESONIDE

CREAM;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%	CREAM;TOPICAL	Prescription	No	AB	214396	ALEMBIC
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	210198	CADILA
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	074027	COSETTE
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	073548	SUN PHARMA CANADA
DESOWEN	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	019048	GALDERMA LABS LP