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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 088597


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NDA 088597 describes PROCHLORPERAZINE EDISYLATE, which is a drug marketed by 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, Watson Labs, Wyeth Ayerst, and Alpharma Us Pharms, and is included in twenty-three NDAs. It is available from sixteen suppliers. Additional details are available on the PROCHLORPERAZINE EDISYLATE profile page.

The generic ingredient in PROCHLORPERAZINE EDISYLATE is prochlorperazine edisylate. There are twenty-one drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the prochlorperazine edisylate profile page.
Summary for 088597
Tradename:PROCHLORPERAZINE EDISYLATE
Applicant:Morton Grove
Ingredient:prochlorperazine edisylate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrengthEQ 5MG BASE/5ML
Approval Date:Oct 25, 1984TE:RLD:No

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