Details for New Drug Application (NDA): 020825
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NDA 020825 describes GEODON, which is a drug marketed by Viatris and Pfizer Inc and is included in three NDAs. It is available from three suppliers. Additional details are available on the GEODON profile page.
The generic ingredient in GEODON 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 GEODON 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 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 | 0049-0056 | 0049-0056-60 | 60 CAPSULE in 1 BOTTLE (0049-0056-60) |
| GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825 | NDA | ROERIG | 0049-0058 | 0049-0058-60 | 60 CAPSULE in 1 BOTTLE (0049-0058-60) |
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 | ||||
| Regulatory Exclusivity Expiration: | Jan 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | ||||||||
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 | ||||
| Regulatory Exclusivity Expiration: | Jan 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | ||||||||
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 | ||||
| Regulatory Exclusivity Expiration: | Jan 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | ||||||||
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 | 5,312,925 | ⤷ Subscribe |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-004 | Feb 5, 2001 | 5,312,925 | ⤷ Subscribe |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-002 | Feb 5, 2001 | 4,831,031 | ⤷ Subscribe |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-003 | Feb 5, 2001 | 4,831,031 | ⤷ Subscribe |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-001 | Feb 5, 2001 | 4,831,031 | ⤷ Subscribe |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-004 | Feb 5, 2001 | 6,150,366 | ⤷ Subscribe |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-002 | Feb 5, 2001 | 6,150,366 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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