Details for New Drug Application (NDA): 020825
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The generic ingredient in GEODON is ziprasidone mesylate. There are two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ziprasidone mesylate profile page.
Summary for 020825
| Tradename: | GEODON |
| Applicant: | Viatris |
| Ingredient: | ziprasidone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020825
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825 | NDA | ROERIG | 0049-0352 | 0049-0352-60 | 60 CAPSULE in 1 BOTTLE (0049-0352-60) |
| GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825 | NDA | ROERIG | 0049-0354 | 0049-0354-60 | 60 CAPSULE in 1 BOTTLE (0049-0354-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Feb 5, 2001 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Feb 5, 2001 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Feb 5, 2001 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020825
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-003 | Feb 5, 2001 | ⤷ Start Trial | ⤷ Start Trial |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-002 | Feb 5, 2001 | ⤷ Start Trial | ⤷ Start Trial |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-001 | Feb 5, 2001 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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