Details for New Drug Application (NDA): 020825
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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 | 020825-004 | Feb 5, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-004 | Feb 5, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-003 | Feb 5, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-001 | Feb 5, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-001 | Feb 5, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-002 | Feb 5, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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