Details for New Drug Application (NDA): 020617
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The generic ingredient in PYTEST KIT is urea, c-14. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the urea, c-14 profile page.
Summary for 020617
Tradename: | PYTEST KIT |
Applicant: | Avent |
Ingredient: | urea, c-14 |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020617
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PYTEST | urea, c-14 | CAPSULE;ORAL | 020617 | NDA | Avent, Inc. | 42536-6044 | 42536-6044-1 | 1 BLISTER PACK in 1 PACKAGE (42536-6044-1) / 1 CAPSULE in 1 BLISTER PACK |
PYTEST | urea, c-14 | CAPSULE;ORAL | 020617 | NDA | Avent, Inc. | 42536-6044 | 42536-6044-2 | 10 CAPSULE in 1 PACKAGE (42536-6044-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1uCi | ||||
Approval Date: | May 9, 1997 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1uCi | ||||
Approval Date: | May 9, 1997 | TE: | RLD: | Yes |
Expired US Patents for NDA 020617
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Avent | PYTEST | urea, c-14 | CAPSULE;ORAL | 020617-001 | May 9, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Avent | PYTEST KIT | urea, c-14 | CAPSULE;ORAL | 020617-002 | May 9, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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