Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020617

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PYTEST (UREA, C-14)
1uCi
Marketing Status: Prescription

Active Ingredient: UREA, C-14
Proprietary Name: PYTEST
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1uCi
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020617
Product Number: 001
Approval Date: May 9, 1997
Applicant Holder Full Name: AVENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PYTEST KIT (UREA, C-14)
1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: UREA, C-14
Proprietary Name: PYTEST KIT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020617
Product Number: 002
Approval Date: May 9, 1997
Applicant Holder Full Name: AVENT INC
Marketing Status:  Discontinued
Patent and Exclusivity Information