Details for New Drug Application (NDA): 040627
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NDA 040627 describes BENZONATATE, which is a drug marketed by Acella, Ascent Pharms Inc, Bionpharma, Chartwell Rx, Cspc-nbp Pharm, Heritage Pharms Labs, Mikart, Nesher Pharms, Puracap Pharm Llc, Strides Pharma, Sun Pharm Inds Inc, Thepharmanetwork Llc, and Zydus Pharms Usa, and is included in thirteen NDAs. It is available from forty-three suppliers. Additional details are available on the BENZONATATE profile page.
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.
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 040627
| Tradename: | BENZONATATE |
| Applicant: | Thepharmanetwork Llc |
| Ingredient: | benzonatate |
| Patents: | 0 |
Pharmacology for NDA: 040627
| Physiological Effect | Decreased Tracheobronchial Stretch Receptor Activity |
Suppliers and Packaging for NDA: 040627
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENZONATATE | benzonatate | CAPSULE;ORAL | 040627 | ANDA | RPK Pharmaceuticals, Inc. | 53002-5890 | 53002-5890-1 | 10 CAPSULE in 1 BOTTLE (53002-5890-1) |
| BENZONATATE | benzonatate | CAPSULE;ORAL | 040627 | ANDA | RPK Pharmaceuticals, Inc. | 53002-5890 | 53002-5890-2 | 20 CAPSULE in 1 BOTTLE (53002-5890-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 30, 2007 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Jul 25, 2007 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Sep 24, 2014 | TE: | RLD: | No | |||||
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