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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 040058

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NDA 040058 describes PROCHLORPERAZINE, which is a drug marketed by Alpharma Us Pharms, Baxter Hlthcare, Able, Cosette, Watson Labs, Morton Grove, Amneal, Avet Lifesciences, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Marsam Pharms Llc, Mylan Labs Ltd, Nexus, Sagent, Smith And Nephew, Somerset Theraps Llc, Teva Parenteral, Viwit Pharm, Wyeth Ayerst, Ajanta Pharma Ltd, Bionpharma, Chartwell Rx, Duramed Pharms Barr, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Leading, Norvium Bioscience, Novitium Pharma, Teva Pharms, and Zydus Lifesciences, and is included in forty-six NDAs. It is available from one supplier. Additional details are available on the PROCHLORPERAZINE profile page.

The generic ingredient in PROCHLORPERAZINE is prochlorperazine maleate. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.

Summary for 040058

Tradename:	PROCHLORPERAZINE
Applicant:	Cosette
Ingredient:	prochlorperazine
Patents:	0

Pharmacology for NDA: 040058

Medical Subject Heading (MeSH) Categories for 040058

Antiemetics
Antipsychotic Agents
Dopamine Antagonists

Suppliers and Packaging for NDA: 040058

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROCHLORPERAZINE	prochlorperazine	SUPPOSITORY;RECTAL	040058	ANDA	Cosette Pharmaceuticals, Inc.	0713-0135	0713-0135-10	1000 BLISTER PACK in 1 CARTON (0713-0135-10) / 1 SUPPOSITORY in 1 BLISTER PACK
PROCHLORPERAZINE	prochlorperazine	SUPPOSITORY;RECTAL	040058	ANDA	Cosette Pharmaceuticals, Inc.	0713-0135	0713-0135-12	12 BLISTER PACK in 1 CARTON (0713-0135-12) / 1 SUPPOSITORY in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUPPOSITORY;RECTAL			Strength	25MG
Approval Date:	Nov 24, 1993	TE:	AB	RLD:	No

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