Details for New Drug Application (NDA): 091632
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NDA 091632 describes HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, which is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX profile page.
The generic ingredient in HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX is chlorpheniramine polistirex; hydrocodone polistirex. There are twenty-nine drug master file entries for this compound. Three 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 CHLORPHENIRAMINE POLISTIREX is chlorpheniramine polistirex; hydrocodone polistirex. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the chlorpheniramine polistirex; hydrocodone polistirex profile page.
Summary for 091632
| Tradename: | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX |
| Applicant: | Tris Pharma Inc |
| Ingredient: | chlorpheniramine polistirex; hydrocodone polistirex |
| Patents: | 0 |
Pharmacology for NDA: 091632
| Mechanism of Action | Histamine H1 Receptor Antagonists Opioid Agonists |
Suppliers and Packaging for NDA: 091632
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX | chlorpheniramine polistirex; hydrocodone polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 091632 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0087 | 17856-0087-2 | 1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0087-2) / 5 BOX, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-3) / 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-1) / 5 mL in 1 CUP, UNIT-DOSE |
| HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX | chlorpheniramine polistirex; hydrocodone polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 091632 | ANDA | Tris Pharma Inc | 27808-086 | 27808-086-01 | 1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-086-01) / 115 mL in 1 BOTTLE, UNIT-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;ORAL | Strength | EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML | ||||
| Approval Date: | Oct 1, 2010 | TE: | RLD: | No | |||||
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