Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216786

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METHSCOPOLAMINE BROMIDE (METHSCOPOLAMINE BROMIDE)
2.5MG
Marketing Status: Prescription

Active Ingredient: METHSCOPOLAMINE BROMIDE
Proprietary Name: METHSCOPOLAMINE BROMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A216786
Product Number: 001
Approval Date: Feb 1, 2024
Applicant Holder Full Name: AACE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METHSCOPOLAMINE BROMIDE (METHSCOPOLAMINE BROMIDE)
5MG
Marketing Status: Prescription

Active Ingredient: METHSCOPOLAMINE BROMIDE
Proprietary Name: METHSCOPOLAMINE BROMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A216786
Product Number: 002
Approval Date: Feb 1, 2024
Applicant Holder Full Name: AACE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information