Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211027
Company: MYLAN

Products on ANDA 211027

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HALCINONIDE	HALCINONIDE	0.1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211027

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211027Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 211027

HALCINONIDE

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALCINONIDE	HALCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	214723	CHARTWELL RX
HALCINONIDE	HALCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	211027	MYLAN
HALOG	HALCINONIDE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	017556	SUN PHARM INDS INC