Details for New Drug Application (NDA): 011210
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The generic ingredient in TESSALON is benzonatate. There are six drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
Summary for 011210
Tradename: | TESSALON |
Applicant: | Pfizer |
Ingredient: | benzonatate |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jun 25, 1999 | TE: | RLD: | Yes |
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