Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211764
Company: COSETTE PHARMS NC

Products on ANDA 211764

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	OINTMENT;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211764

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211764

HYDROCORTISONE VALERATE

OINTMENT;TOPICAL; 0.2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	OINTMENT;TOPICAL	Prescription	No	AB	211764	COSETTE PHARMS NC
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	OINTMENT;TOPICAL	Prescription	No	AB	075043	SUN PHARMA CANADA