Details for New Drug Application (NDA): 091133
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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 091133
Tradename: | BENZONATATE |
Applicant: | Strides Pharma |
Ingredient: | benzonatate |
Patents: | 0 |
Pharmacology for NDA: 091133
Physiological Effect | Decreased Tracheobronchial Stretch Receptor Activity |
Suppliers and Packaging for NDA: 091133
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BENZONATATE | benzonatate | CAPSULE;ORAL | 091133 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8403 | 0615-8403-05 | 15 CAPSULE in 1 BLISTER PACK (0615-8403-05) |
BENZONATATE | benzonatate | CAPSULE;ORAL | 091133 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8403 | 0615-8403-21 | 21 CAPSULE in 1 BLISTER PACK (0615-8403-21) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jul 30, 2015 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Jul 30, 2015 | TE: | AA | RLD: | No |
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