Details for New Drug Application (NDA): 091671
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NDA 091671 describes HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, which is a drug marketed by Neos Theraps Inc and is included in one NDA. It is available from one supplier. Additional details are available on the HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX profile page.
The generic ingredient in HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX is chlorpheniramine polistirex; hydrocodone polistirex. There are twenty-nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chlorpheniramine polistirex; hydrocodone polistirex profile page.
The generic ingredient in HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX is chlorpheniramine polistirex; hydrocodone polistirex. There are twenty-nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chlorpheniramine polistirex; hydrocodone polistirex profile page.
Summary for 091671
| Tradename: | HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX |
| Applicant: | Neos Theraps Inc |
| Ingredient: | chlorpheniramine polistirex; hydrocodone polistirex |
| Patents: | 0 |
Pharmacology for NDA: 091671
| Mechanism of Action | Histamine H1 Receptor Antagonists Opioid Agonists |
Suppliers and Packaging for NDA: 091671
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX | chlorpheniramine polistirex; hydrocodone polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 091671 | ANDA | Neos Therapeutics LP | 62542-301 | 62542-301-03 | 70 mL in 1 BOTTLE, GLASS (62542-301-03) |
| HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX | chlorpheniramine polistirex; hydrocodone polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 091671 | ANDA | Neos Therapeutics LP | 62542-301 | 62542-301-04 | 118 mL in 1 BOTTLE, GLASS (62542-301-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION, EXTENDED RELEASE;ORAL | Strength | EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML | ||||
| Approval Date: | Jun 29, 2012 | TE: | RLD: | No | |||||
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