Details for New Drug Application (NDA): 207487
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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 207487
Tradename: | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
Applicant: | Abhai Llc |
Ingredient: | homatropine methylbromide; hydrocodone bitartrate |
Patents: | 0 |
Pharmacology for NDA: 207487
Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 207487
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 | 207487 | ANDA | KVK-Tech, Inc. | 10702-150 | 10702-150-16 | 473 mL in 1 BOTTLE (10702-150-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 1.5MG/5ML;5MG/5ML | ||||
Approval Date: | Feb 21, 2017 | TE: | AA | RLD: | No |
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