Details for New Drug Application (NDA): 091135
✉ Email this page to a colleague
NDA 091135 describes DEXTROMETHORPHAN POLISTIREX, which is a drug marketed by Amneal and Tris Pharma Inc and is included in two NDAs. It is available from twenty-six suppliers. Additional details are available on the DEXTROMETHORPHAN POLISTIREX profile page.
The generic ingredient in DEXTROMETHORPHAN POLISTIREX is dextromethorphan polistirex. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan polistirex profile page.
The generic ingredient in DEXTROMETHORPHAN POLISTIREX is dextromethorphan polistirex. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan polistirex profile page.
Summary for 091135
| Tradename: | DEXTROMETHORPHAN POLISTIREX |
| Applicant: | Tris Pharma Inc |
| Ingredient: | dextromethorphan polistirex |
| Patents: | 0 |
Pharmacology for NDA: 091135
| Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 091135
Suppliers and Packaging for NDA: 091135
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROMETHORPHAN POLISTIREX | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 091135 | ANDA | Haleon US Holdings LLC | 0031-8655 | 0031-8655-10 | 1 BOTTLE in 1 CARTON (0031-8655-10) / 89 mL in 1 BOTTLE |
| DEXTROMETHORPHAN POLISTIREX | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 091135 | ANDA | Haleon US Holdings LLC | 0031-8725 | 0031-8725-10 | 1 BOTTLE in 1 CARTON (0031-8725-10) / 89 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION, EXTENDED RELEASE;ORAL | Strength | EQ 30MG HYDROBROMIDE/5ML | ||||
| Approval Date: | May 25, 2012 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
