Details for New Drug Application (NDA): 211908
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NDA 211908 describes ZIPRASIDONE MESYLATE, which is a drug marketed by Gland Pharma Ltd and MSN and is included in two NDAs. It is available from five 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the ziprasidone mesylate profile page.
Summary for 211908
| Tradename: | ZIPRASIDONE MESYLATE |
| Applicant: | Gland Pharma Ltd |
| 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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