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Details for New Drug Application (NDA): 089903

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NDA 089903 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: 089903

Tradename:
PROCHLORPERAZINE EDISYLATE
Applicant:
Eurohlth Intl Sarl
Ingredient:
prochlorperazine edisylate
Patents:0
Therapeutic Class:Antiemetics
Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 089903

Ingredient-typePhenothiazines

Suppliers and Packaging for NDA: 089903

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROCHLORPERAZINE EDISYLATE
prochlorperazine edisylate
INJECTABLE;INJECTION 089903 ANDA Baxter Healthcare Corporation 0641-0491 0641-0491-25 25 VIAL in 1 PACKAGE (0641-0491-25) > 2 mL in 1 VIAL (0641-0491-21)
PROCHLORPERAZINE EDISYLATE
prochlorperazine edisylate
INJECTABLE;INJECTION 089903 ANDA West-Ward Pharmaceuticals Corp. 0641-6135 0641-6135-25 25 VIAL in 1 CARTON (0641-6135-25) > 2 mL in 1 VIAL (0641-6135-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Aug 29, 1989TE:APRLD:No


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