Details for New Drug Application (NDA): 211518
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NDA 211518 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-four 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-four 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-four suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
Summary for 211518
| Tradename: | BENZONATATE |
| Applicant: | Ascent Pharms Inc |
| Ingredient: | benzonatate |
| Patents: | 0 |
Pharmacology for NDA: 211518
| Physiological Effect | Decreased Tracheobronchial Stretch Receptor Activity |
Suppliers and Packaging for NDA: 211518
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENZONATATE | benzonatate | CAPSULE;ORAL | 211518 | ANDA | Camber Pharmaceuticals, Inc. | 31722-956 | 31722-956-01 | 100 CAPSULE in 1 BOTTLE (31722-956-01) |
| BENZONATATE | benzonatate | CAPSULE;ORAL | 211518 | ANDA | Camber Pharmaceuticals, Inc. | 31722-956 | 31722-956-05 | 500 CAPSULE in 1 BOTTLE (31722-956-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Feb 22, 2019 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Feb 22, 2019 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Feb 22, 2019 | TE: | AA | RLD: | No | ||||
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