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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 085580


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NDA 085580 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, Teva Parenteral, Viwit Pharm, Wyeth Ayerst, Bionpharma, Chartwell Rx, Duramed Pharms Barr, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Mylan, Novitium Pharma, Teva Pharms, and Zydus, and is included in forty-three 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 suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.
Summary for 085580
Tradename:PROCHLORPERAZINE
Applicant:Watson Labs
Ingredient:prochlorperazine maleate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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