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Details for New Drug Application (NDA): 040540

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NDA 040540 describes PROCHLORPERAZINE EDISYLATE, which is a drug marketed by Eurohlth Intl Sarl, Hospira, Teva Parenteral, Watson Labs, Amphastar Pharms Inc, Emcure Pharms Ltd, Wyeth Ayerst, Smith And Nephew, Alpharma Us Pharms, Marsam Pharms Llc, and Morton Grove, and is included in fifteen NDAs. It is available from seven suppliers. Additional details are available on the PROCHLORPERAZINE EDISYLATE profile page.

The generic ingredient in PROCHLORPERAZINE EDISYLATE is prochlorperazine edisylate. There are seventeen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the prochlorperazine edisylate profile page.

Summary for NDA: 040540

Amphastar Pharms Inc
prochlorperazine edisylate
Therapeutic Class:Antiemetics

Pharmacology for NDA: 040540


Suppliers and Packaging for NDA: 040540

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
prochlorperazine edisylate
INJECTABLE;INJECTION 040540 ANDA General Injectables & Vaccines, Inc 52584-077 52584-077-10 1 VIAL in 1 BAG (52584-077-10) > 2 mL in 1 VIAL
prochlorperazine edisylate
INJECTABLE;INJECTION 040540 ANDA Physicians Total Care, Inc. 54868-0261 54868-0261-0 1 VIAL in 1 BOX, UNIT-DOSE (54868-0261-0) > 10 mL in 1 VIAL

Summary for product number 001

Approval Date:May 28, 2004TE:RLD:No

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