Details for New Drug Application (NDA): 203133
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NDA 203133 describes DEXTROMETHORPHAN POLISTIREX, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, and Tris Pharma Inc, and is included in three NDAs. It is available from twenty-eight suppliers. Additional details are available on the DEXTROMETHORPHAN POLISTIREX profile page.
The generic ingredient in DEXTROMETHORPHAN POLISTIREX is dextromethorphan polistirex. There is one drug master file entry for this compound. Thirty 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 is one drug master file entry for this compound. Thirty 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 |
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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