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Last Updated: April 18, 2021

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Details for New Drug Application (NDA): 040058

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NDA 040058 describes PROCHLORPERAZINE, which is a drug marketed by Alpharma Us Pharms, Baxter Hlthcare, Able, Cosette, Watson Labs, Morton Grove, Athenex Inc, Emcure Pharms Ltd, Hospira, Marsam Pharms Llc, Mylan Labs Ltd, Nexus Pharms, Smith And Nephew, Teva Parenteral, West-ward Pharms Int, Wyeth Ayerst, Duramed Pharms Barr, Ivax Sub Teva Pharms, Mylan, Sandoz, and Teva Pharms, and is included in thirty-two NDAs. It is available from two suppliers. 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. Seventeen suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.
Summary for 040058
Tradename:PROCHLORPERAZINE
Applicant:Cosette
Ingredient:prochlorperazine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040058
Medical Subject Heading (MeSH) Categories for 040058
Suppliers and Packaging for NDA: 040058
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROCHLORPERAZINE prochlorperazine SUPPOSITORY;RECTAL 040058 ANDA Cosette Pharmaceuticals, Inc. 0713-0135 0713-0135-10 1000 BLISTER PACK in 1 CARTON (0713-0135-10) > 1 SUPPOSITORY in 1 BLISTER PACK
PROCHLORPERAZINE prochlorperazine SUPPOSITORY;RECTAL 040058 ANDA Cosette Pharmaceuticals, Inc. 0713-0135 0713-0135-12 12 BLISTER PACK in 1 CARTON (0713-0135-12) > 1 SUPPOSITORY in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength25MG
Approval Date:Nov 24, 1993TE:ABRLD:No

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