Details for New Drug Application (NDA): 217340
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NDA 217340 describes GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Perrigo R And D, and Sun Pharm, and is included in six NDAs. It is available from fifty-nine suppliers. Additional details are available on the GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE profile page.
The generic ingredient in GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
The generic ingredient in GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for 217340
| Tradename: | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE |
| Applicant: | Dr Reddys |
| Ingredient: | dextromethorphan hydrobromide; guaifenesin |
| Patents: | 0 |
Pharmacology for NDA: 217340
| Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Suppliers and Packaging for NDA: 217340
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 217340 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-114 | 43598-114-01 | 5 BLISTER PACK in 1 CARTON (43598-114-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 217340 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-114 | 43598-114-20 | 1 BLISTER PACK in 1 CARTON (43598-114-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG;600MG | ||||
| Approval Date: | Aug 1, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG;1.2GM | ||||
| Approval Date: | Aug 1, 2023 | TE: | RLD: | No | |||||
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