Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216626
Company: AMNEAL

Products on ANDA 216626

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216626

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216626

POSACONAZOLE

TABLET, DELAYED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NOXAFIL	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	205053	MERCK SHARP DOHME
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	213454	AET PHARMA
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216626	AMNEAL
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	214476	BIOCON PHARMA
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	212500	DR REDDYS
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	214321	HETERO LABS LTD III
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216488	I 3 PHARMS
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	212411	SINOTHERAPEUTICS INC
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	212226	SPECGX LLC
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216326	WESTMINSTER PHARMS