Details for New Drug Application (NDA): 206986
✉ Email this page to a colleague
The generic ingredient in HYDROCODONE BITARTRATE is chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.
Summary for 206986
Tradename: | HYDROCODONE BITARTRATE |
Applicant: | Alvogen |
Ingredient: | hydrocodone bitartrate |
Patents: | 0 |
Pharmacology for NDA: 206986
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 206986
Suppliers and Packaging for NDA: 206986
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 206986 | ANDA | Alvogen Inc. | 47781-409 | 47781-409-60 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-409-60) |
HYDROCODONE BITARTRATE | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 206986 | ANDA | Alvogen Inc. | 47781-410 | 47781-410-60 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-410-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 21, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Jan 21, 2020 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
Approval Date: | Jan 21, 2020 | TE: | RLD: | No |
Complete Access Available with Subscription