Details for New Drug Application (NDA): 217780
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The generic ingredient in GUAIFENESIN is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
Summary for 217780
Tradename: | GUAIFENESIN |
Applicant: | Marksans Pharma |
Ingredient: | guaifenesin |
Patents: | 0 |
Pharmacology for NDA: 217780
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Medical Subject Heading (MeSH) Categories for 217780
Suppliers and Packaging for NDA: 217780
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 217780 | ANDA | MARKSANS PHARMA LIMITED | 25000-041 | 25000-041-12 | 500 TABLET in 1 BOTTLE (25000-041-12) |
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 217780 | ANDA | MARKSANS PHARMA LIMITED | 25000-041 | 25000-041-75 | 2 BLISTER PACK in 1 CARTON (25000-041-75) / 6 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
Approval Date: | Aug 21, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.2GM | ||||
Approval Date: | Aug 21, 2023 | TE: | RLD: | No |
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