Details for New Drug Application (NDA): 218417
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NDA 218417 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-nine 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. Thirty-one 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. Thirty-one suppliers are listed for this compound. Additional details are available on the dextromethorphan polistirex profile page.
Summary for 218417
| Tradename: | DEXTROMETHORPHAN POLISTIREX |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | dextromethorphan polistirex |
| Patents: | 0 |
Pharmacology for NDA: 218417
| Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 218417
Suppliers and Packaging for NDA: 218417
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROMETHORPHAN POLISTIREX | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 218417 | ANDA | Aurohealth LLC | 58602-610 | 58602-610-05 | 1 BOTTLE in 1 CARTON (58602-610-05) / 89 mL in 1 BOTTLE |
| DEXTROMETHORPHAN POLISTIREX | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 218417 | ANDA | Aurohealth LLC | 58602-610 | 58602-610-06 | 1 BOTTLE in 1 CARTON (58602-610-06) / 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: | Apr 15, 2026 | TE: | RLD: | No | |||||
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