Details for New Drug Application (NDA): 213630
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NDA 213630 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, Somerset Theraps Llc, Teva Parenteral, Viwit Pharm, Watson Labs, Wyeth Ayerst, and Alpharma Us Pharms, and is included in twenty-four NDAs. It is available from seventeen 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. Seventeen suppliers are listed for this compound. 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. Seventeen suppliers are listed for this compound. Additional details are available on the prochlorperazine edisylate profile page.
Summary for 213630
| Tradename: | PROCHLORPERAZINE EDISYLATE |
| Applicant: | Hikma |
| Ingredient: | prochlorperazine edisylate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213630
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCHLORPERAZINE EDISYLATE | prochlorperazine edisylate | INJECTABLE;INJECTION | 213630 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6225 | 0641-6225-10 | 10 SYRINGE in 1 CARTON (0641-6225-10) / 2 mL in 1 SYRINGE (0641-6225-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
| Approval Date: | Nov 22, 2022 | TE: | RLD: | No | |||||
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