Details for New Drug Application (NDA): 210663
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NDA 210663 describes HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, which is a drug marketed by Abhai Llc, Actavis Mid Atlantic, Genus, Ivax Sub Teva Pharms, Nostrum Labs Inc, Novel Labs Inc, Padagis Us, Sciegen Pharms Inc, and Wockhardt Bio Ag, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE profile page.
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.
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 210663
| Tradename: | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
| Applicant: | Nostrum Labs Inc |
| Ingredient: | homatropine methylbromide; hydrocodone bitartrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 1.5MG/5ML;5MG/5ML | ||||
| Approval Date: | Jun 11, 2019 | TE: | RLD: | No | |||||
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