Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 011210

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TESSALON (BENZONATATE)
100MG
Marketing Status: Prescription

Active Ingredient: BENZONATATE
Proprietary Name: TESSALON
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AA
Application Number: N011210
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TESSALON (BENZONATATE)
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: BENZONATATE
Proprietary Name: TESSALON
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011210
Product Number: 003
Approval Date: Jun 25, 1999
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information