Details for New Drug Application (NDA): 211023
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The generic ingredient in HYDROCODONE BITARTRATE AND ACETAMINOPHEN is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 211023
Tradename: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
Applicant: | Wes Pharma Inc |
Ingredient: | acetaminophen; hydrocodone bitartrate |
Patents: | 0 |
Pharmacology for NDA: 211023
Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 211023
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | SOLUTION;ORAL | 211023 | ANDA | American Health Packaging | 60687-417 | 60687-417-71 | 5 TRAY in 1 CASE (60687-417-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-417-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-417-44) |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | SOLUTION;ORAL | 211023 | ANDA | Eywa Pharma Inc | 71930-027 | 71930-027-43 | 473 mL in 1 BOTTLE (71930-027-43) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 325MG/15ML;7.5MG/15ML | ||||
Approval Date: | Mar 8, 2019 | TE: | AA | RLD: | No |
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