Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211181

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PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE)
30MG
Marketing Status: Prescription

Active Ingredient: PYRIDOSTIGMINE BROMIDE
Proprietary Name: PYRIDOSTIGMINE BROMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211181
Product Number: 002
Approval Date: May 14, 2019
Applicant Holder Full Name: MLV PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE)
60MG
Marketing Status: Prescription

Active Ingredient: PYRIDOSTIGMINE BROMIDE
Proprietary Name: PYRIDOSTIGMINE BROMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211181
Product Number: 001
Approval Date: Jul 20, 2018
Applicant Holder Full Name: MLV PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information