Details for New Drug Application (NDA): 203535
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NDA 203535 describes HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, which is a drug marketed by Abhai Llc, Actavis Mid Atlantic, Genus Lifesciences, Ivax Sub Teva Pharms, Novel Labs Inc, Padagis Us, Pharmobedient, Sankalp Lifecare, and Sciegen Pharms Inc, 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 203535
| Tradename: | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
| Applicant: | Novel Labs Inc |
| Ingredient: | homatropine methylbromide; hydrocodone bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 203535
| Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 203535
| 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 | 203535 | ANDA | Novel Laboratories, Inc. | 40032-810 | 40032-810-05 | 473 mL in 1 BOTTLE (40032-810-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 1.5MG/5ML;5MG/5ML | ||||
| Approval Date: | Feb 13, 2017 | TE: | AA | RLD: | No | ||||
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