Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022524

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ZUPLENZ (ONDANSETRON)
4MG
Marketing Status: Discontinued
Active Ingredient: ONDANSETRON
Proprietary Name: ZUPLENZ
Dosage Form; Route of Administration: FILM; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022524
Product Number: 001
Approval Date: Jul 2, 2010
Applicant Holder Full Name: AQUESTIVE THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ZUPLENZ (ONDANSETRON)
8MG
Marketing Status: Discontinued
Active Ingredient: ONDANSETRON
Proprietary Name: ZUPLENZ
Dosage Form; Route of Administration: FILM; ORAL
Strength: 8MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022524
Product Number: 002
Approval Date: Jul 2, 2010
Applicant Holder Full Name: AQUESTIVE THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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