Details for New Drug Application (NDA): 202765
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The generic ingredient in BENZONATATE is benzonatate. There are six drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
Summary for 202765
Tradename: | BENZONATATE |
Applicant: | Cspc-nbp Pharm |
Ingredient: | benzonatate |
Patents: | 0 |
Pharmacology for NDA: 202765
Physiological Effect | Decreased Tracheobronchial Stretch Receptor Activity |
Suppliers and Packaging for NDA: 202765
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BENZONATATE | benzonatate | CAPSULE;ORAL | 202765 | ANDA | A-S Medication Solutions | 50090-4968 | 50090-4968-0 | 15 CAPSULE in 1 BOTTLE (50090-4968-0) |
BENZONATATE | benzonatate | CAPSULE;ORAL | 202765 | ANDA | A-S Medication Solutions | 50090-4969 | 50090-4969-0 | 20 CAPSULE in 1 BOTTLE (50090-4969-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Jul 31, 2015 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 25, 2017 | TE: | AA | RLD: | No |
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