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Details for New Drug Application (NDA): 040058
» See Plans and Pricing
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.
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 |
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: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 25MG | ||||
| Approval Date: | Nov 24, 1993 | TE: | AB | RLD: | No | ||||
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