Details for New Drug Application (NDA): 088008
✉ Email this page to a colleague
The generic ingredient in HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE is homatropine methylbromide; hydrocodone bitartrate. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the homatropine methylbromide; hydrocodone bitartrate profile page.
Summary for 088008
Tradename: | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
Applicant: | Wockhardt Bio Ag |
Ingredient: | homatropine methylbromide; hydrocodone bitartrate |
Patents: | 0 |
Pharmacology for NDA: 088008
Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 088008
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | homatropine methylbromide; hydrocodone bitartrate | SYRUP;ORAL | 088008 | ANDA | Pharmaceutical Associates, Inc. | 0121-4811 | 0121-4811-40 | 4 TRAY in 1 CASE (0121-4811-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4811-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 1.5MG/5ML;5MG/5ML | ||||
Approval Date: | Mar 3, 1983 | TE: | AA | RLD: | No |
Complete Access Available with Subscription