Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040268
Company: JUBILANT CADISTA

Products on ANDA 40268

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

Labels for ANDA 040268

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/22/2025	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/040268Orig1s033lbl.pdf