Details for New Drug Application (NDA): 209215
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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 209215
Tradename: | GUAIFENESIN |
Applicant: | Guardian Drug |
Ingredient: | guaifenesin |
Patents: | 0 |
Pharmacology for NDA: 209215
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Medical Subject Heading (MeSH) Categories for 209215
Suppliers and Packaging for NDA: 209215
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 209215 | ANDA | Major Pharmaceuticals | 0904-6986 | 0904-6986-40 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6986-40) |
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 209215 | ANDA | Safeway | 21130-206 | 21130-206-58 | 2 BLISTER PACK in 1 CARTON (21130-206-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
Approval Date: | Sep 6, 2017 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.2GM | ||||
Approval Date: | Sep 6, 2017 | TE: | RLD: | No |
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