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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206948

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BENZONATATE (BENZONATATE)
100MG
Marketing Status: Prescription
Active Ingredient: BENZONATATE
Proprietary Name: BENZONATATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A206948
Product Number: 001
Approval Date: Dec 19, 2018
Applicant Holder Full Name: PURACAP PHARMACEUTICAL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
BENZONATATE (BENZONATATE)
200MG
Marketing Status: Prescription
Active Ingredient: BENZONATATE
Proprietary Name: BENZONATATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A206948
Product Number: 002
Approval Date: Dec 19, 2018
Applicant Holder Full Name: PURACAP PHARMACEUTICAL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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