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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214502
Company: ZYDUS

Products on ANDA 214502

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIMAVANSERIN	PIMAVANSERIN TARTRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214502

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214502Orig1s000TA_ltr.pdf

Therapeutic Equivalents for ANDA 214502

PIMAVANSERIN

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NUPLAZID	PIMAVANSERIN TARTRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	207318	ACADIA PHARMS INC
PIMAVANSERIN	PIMAVANSERIN TARTRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	214502	ZYDUS

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