Details for New Drug Application (NDA): 091528
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NDA 091528 describes HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, which is a drug marketed by Actavis Elizabeth, Avanthi Inc, and Novel Labs Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE profile page.
The generic ingredient in HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 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 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 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 091528
| Tradename: | HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE |
| Applicant: | Novel Labs Inc |
| Ingredient: | homatropine methylbromide; hydrocodone bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 091528
| Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 091528
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE | homatropine methylbromide; hydrocodone bitartrate | TABLET;ORAL | 091528 | ANDA | Novel Laboratories, Inc. | 40032-118 | 40032-118-03 | 30 TABLET in 1 BOTTLE (40032-118-03) |
| HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE | homatropine methylbromide; hydrocodone bitartrate | TABLET;ORAL | 091528 | ANDA | Novel Laboratories, Inc. | 40032-118 | 40032-118-24 | 100 TABLET in 1 BOTTLE (40032-118-24) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1.5MG;5MG | ||||
| Approval Date: | Apr 20, 2011 | TE: | RLD: | No | |||||
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