Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211750
Company: GLENMARK PHARMS LTD

Products on ANDA 211750

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 211750

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211750Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 211750

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
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	OINTMENT;TOPICAL	Prescription	No	AB	211750	GLENMARK PHARMS LTD
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	OINTMENT;TOPICAL	Prescription	No	AB	075043	TARO