Details for New Drug Application (NDA): 005213
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NDA 005213 describes HYCODAN, which is a drug marketed by Genus and is included in one NDA. It is available from two suppliers. Additional details are available on the HYCODAN profile page.
The generic ingredient in HYCODAN 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 HYCODAN 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 005213
| Tradename: | HYCODAN |
| Applicant: | Genus |
| Ingredient: | homatropine methylbromide; hydrocodone bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 005213
| Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 005213
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYCODAN | homatropine methylbromide; hydrocodone bitartrate | SYRUP;ORAL | 005213 | NDA AUTHORIZED GENERIC | PAI Holdings, LLC dba PAI Pharma | 0121-1036 | 0121-1036-40 | 4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05) |
| HYCODAN | homatropine methylbromide; hydrocodone bitartrate | SYRUP;ORAL | 005213 | NDA | Genus Lifesciences Inc. | 64950-205 | 64950-205-03 | 30 TABLET in 1 BOTTLE, PLASTIC (64950-205-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 26, 1988 | TE: | AA | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 26, 1988 | TE: | AA | RLD: | Yes | ||||
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