Details for New Drug Application (NDA): 040682
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The generic ingredient in BENZONATATE 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 040682
Tradename: | BENZONATATE |
Applicant: | Heritage Pharms Labs |
Ingredient: | benzonatate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040682
Physiological Effect | Decreased Tracheobronchial Stretch Receptor Activity |
Suppliers and Packaging for NDA: 040682
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BENZONATATE | benzonatate | CAPSULE;ORAL | 040682 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-979 | 43063-979-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (43063-979-01) |
BENZONATATE | benzonatate | CAPSULE;ORAL | 040682 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-980 | 43063-980-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (43063-980-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jul 30, 2007 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Jul 30, 2007 | TE: | AA | RLD: | No |
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