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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217478
Company: BIONPHARMA

Products on ANDA 217478

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217478

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/2023	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
01/22/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 217478

PROCHLORPERAZINE MALEATE

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	218515	AJANTA PHARMA LTD
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	216598	AMNEAL
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	218734	AUROBINDO PHARMA LTD
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	217478	BIONPHARMA
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	217847	DR REDDYS LABS SA
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	216595	GLENMARK PHARMS LTD
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	218912	LEADING
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	216202	NOVITIUM PHARMA
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	216495	ZYDUS LIFESCIENCES
PROCOMP	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	040268	JUBILANT CADISTA

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	218515	AJANTA PHARMA LTD
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	216598	AMNEAL
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	218734	AUROBINDO PHARMA LTD
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	217478	BIONPHARMA
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	217847	DR REDDYS LABS SA
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	216595	GLENMARK PHARMS LTD
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	218912	LEADING
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	216202	NOVITIUM PHARMA
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	216495	ZYDUS LIFESCIENCES
PROCOMP	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	040268	JUBILANT CADISTA

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