Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213454
Company: AET PHARMA

Products on ANDA 213454

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213454

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2023	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
12/18/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/18/2023	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
12/18/2023	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213454

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
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	217119	AUROBINDO PHARMA
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