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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215019

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DARTISLA ODT (GLYCOPYRROLATE)
0.85MG
Marketing Status: Discontinued
Active Ingredient: GLYCOPYRROLATE
Proprietary Name: DARTISLA ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 0.85MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N215019
Product Number: 002
Approval Date: Oct 11, 2023
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DARTISLA ODT (GLYCOPYRROLATE)
1.7MG
Marketing Status: Discontinued
Active Ingredient: GLYCOPYRROLATE
Proprietary Name: DARTISLA ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 1.7MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215019
Product Number: 001
Approval Date: Dec 16, 2021
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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