Details for New Drug Application (NDA): 203133
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NDA 203133 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-four 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the dextromethorphan polistirex profile page.
Summary for 203133
| Tradename: | DEXTROMETHORPHAN POLISTIREX |
| Applicant: | Amneal |
| Ingredient: | dextromethorphan polistirex |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203133
| Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 203133
Suppliers and Packaging for NDA: 203133
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROMETHORPHAN POLISTIREX | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 203133 | ANDA | Amneal Pharmaceuticals LLC | 65162-700 | 65162-700-76 | 1 BOTTLE in 1 CARTON (65162-700-76) / 89 mL in 1 BOTTLE |
| DEXTROMETHORPHAN POLISTIREX | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 203133 | ANDA | Amneal Pharmaceuticals LLC | 65162-700 | 65162-700-77 | 1 BOTTLE in 1 CARTON (65162-700-77) / 148 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: | Jul 28, 2017 | TE: | RLD: | No | |||||
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