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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216598
Company: AMNEAL
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/17/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

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 217478 BIONPHARMA
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 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 217478 BIONPHARMA
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 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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