Guaifenesin and Dextromethorphan HBr
INNOVUS PHARMACEUTICALS, INC. · TABLET, EXTENDED RELEASE
- Product NDC
- 57483-114
- Generic name
- Guaifenesin and Dextromethorphan HBr
- Labeler name
- INNOVUS PHARMACEUTICALS, INC.
- Brand name
- Guaifenesin and Dextromethorphan HBr
- Finished
- true
- Listing expiration date
- 20271231
- Marketing category
- ANDA
- Dosage form
- TABLET, EXTENDED RELEASE
- SPL ID
- 376b3f7a-3f5b-4524-aca8-8a62876ec52a
- Product type
- HUMAN OTC DRUG
- Marketing start date
- 20261027
- Product ID
- 57483-114_376b3f7a-3f5b-4524-aca8-8a62876ec52a
- Application number
- ANDA206941
- Brand name base
- Guaifenesin and Dextromethorphan HBr
- Active ingredients
- Name
- GUAIFENESIN
- Strength
- 1200 mg/1
- Name
- DEXTROMETHORPHAN HYDROBROMIDE
- Strength
- 60 mg/1
- Packaging
- Package NDC
- 57483-114-28
- Description
- 4 BLISTER PACK in 1 CARTON (57483-114-28) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- Marketing start date
- 20261027
- Sample
- false
- Route
- ORAL
- Pharm class
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]