Details for New Drug Application (NDA): 211908
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NDA 211908 describes ZIPRASIDONE MESYLATE, which is a drug marketed by Gland, MSN, and Steriscience, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the ZIPRASIDONE MESYLATE profile page.
The generic ingredient in ZIPRASIDONE MESYLATE is ziprasidone mesylate. There is one drug master file entry 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the ziprasidone mesylate profile page.
Summary for 211908
| Tradename: | ZIPRASIDONE MESYLATE |
| Applicant: | Gland |
| Ingredient: | ziprasidone mesylate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211908
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZIPRASIDONE MESYLATE | ziprasidone mesylate | POWDER;INTRAMUSCULAR | 211908 | ANDA | Dr.Reddy's Laboratories, Inc. | 43598-061 | 43598-061-58 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-061-58) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-061-11) |
| ZIPRASIDONE MESYLATE | ziprasidone mesylate | POWDER;INTRAMUSCULAR | 211908 | ANDA | Dr.Reddy's Laboratories, Inc. | 43598-848 | 43598-848-58 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-848-58) / 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: | Dec 26, 2019 | TE: | AP | RLD: | No | ||||
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