Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208773
Company: HIKMA

Products on ANDA 208773

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POSACONAZOLE	POSACONAZOLE	40MG/ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208773

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208773Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2024	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/24/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208773

POSACONAZOLE

SUSPENSION;ORAL; 40MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NOXAFIL	POSACONAZOLE	40MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	022003	SCHERING
POSACONAZOLE	POSACONAZOLE	40MG/ML	SUSPENSION;ORAL	Prescription	No	AB	208773	HIKMA