Details for New Drug Application (NDA): 011210
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NDA 011210 describes TESSALON, which is a drug marketed by Pfizer and is included in one NDA. Additional details are available on the TESSALON profile page.
The generic ingredient in TESSALON is benzonatate. There are six drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
The generic ingredient in TESSALON is benzonatate. There are six drug master file entries for this compound. Forty-seven 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DISCN | Dosage: | CAPSULE;ORAL | Strength | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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