Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211500
Company: MYLAN LABS LTD

Products on ANDA 211500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POSACONAZOLE	POSACONAZOLE	300MG/16.7ML (18MG/ML)	SOLUTION;INTRAVENOUS	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2023	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211500Orig1s000TA_ltr.pdf