Details for New Drug Application (NDA): 217595
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NDA 217595 describes ZIPRASIDONE MESYLATE, which is a drug marketed by Gland, MSN, and Steriscience, and is included in three NDAs. It is available from six suppliers. Additional details are available on the ZIPRASIDONE MESYLATE profile page.
The generic ingredient in ZIPRASIDONE MESYLATE is ziprasidone mesylate. There are twenty-three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ziprasidone mesylate profile page.
The generic ingredient in ZIPRASIDONE MESYLATE is ziprasidone mesylate. There are twenty-three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ziprasidone mesylate profile page.
Summary for 217595
| Tradename: | ZIPRASIDONE MESYLATE |
| Applicant: | Steriscience |
| Ingredient: | ziprasidone mesylate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217595
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZIPRASIDONE MESYLATE | ziprasidone mesylate | POWDER;INTRAMUSCULAR | 217595 | ANDA | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 82449-004 | 82449-004-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ZIPRASIDONE MESYLATE | ziprasidone mesylate | POWDER;INTRAMUSCULAR | 217595 | ANDA | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 82449-004 | 82449-004-02 | 10 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-02) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAMUSCULAR | Strength | EQ 20MG BASE/VIAL | ||||
| Approval Date: | Sep 3, 2025 | TE: | AP | RLD: | No | ||||
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