Details for New Drug Application (NDA): 205731
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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 205731
Tradename: | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
Applicant: | Padagis Us |
Ingredient: | homatropine methylbromide; hydrocodone bitartrate |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 1.5MG/5ML;5MG/5ML | ||||
Approval Date: | Feb 15, 2017 | TE: | AA | RLD: | No |
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