Details for New Drug Application (NDA): 091135
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NDA 091135 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 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 | |||||
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