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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 204147


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NDA 204147 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 204147
Tradename:PROCHLORPERAZINE EDISYLATE
Applicant:Avet Lifesciences
Ingredient:prochlorperazine edisylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204147
Suppliers and Packaging for NDA: 204147
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROCHLORPERAZINE EDISYLATE prochlorperazine edisylate INJECTABLE;INJECTION 204147 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-294 23155-294-41 25 VIAL in 1 PACKAGE (23155-294-41) / 2 mL in 1 VIAL (23155-294-31)
PROCHLORPERAZINE EDISYLATE prochlorperazine edisylate INJECTABLE;INJECTION 204147 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-294 23155-294-42 10 VIAL in 1 PACKAGE (23155-294-42) / 2 mL in 1 VIAL (23155-294-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Oct 15, 2013TE:APRLD:No

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