Details for New Drug Application (NDA): 210710
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NDA 210710 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, Teva Parenteral, Viwit Pharm, Watson Labs, Wyeth Ayerst, and Alpharma Us Pharms, and is included in twenty-three NDAs. It is available from sixteen 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the prochlorperazine edisylate profile page.
Summary for 210710
| Tradename: | PROCHLORPERAZINE EDISYLATE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | prochlorperazine edisylate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210710
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCHLORPERAZINE EDISYLATE | prochlorperazine edisylate | INJECTABLE;INJECTION | 210710 | ANDA | Mylan Institutional LLC | 67457-640 | 67457-640-02 | 25 VIAL in 1 CARTON (67457-640-02) / 2 mL in 1 VIAL (67457-640-00) |
| PROCHLORPERAZINE EDISYLATE | prochlorperazine edisylate | INJECTABLE;INJECTION | 210710 | ANDA | Mylan Institutional LLC | 67457-640 | 67457-640-99 | 10 VIAL in 1 CARTON (67457-640-99) / 2 mL in 1 VIAL (67457-640-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
| Approval Date: | Oct 25, 2018 | TE: | AP | RLD: | No | ||||
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