Details for New Drug Application (NDA): 207342
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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 207342
Tradename: | GUAIFENESIN |
Applicant: | Amneal Pharms |
Ingredient: | guaifenesin |
Patents: | 0 |
Pharmacology for NDA: 207342
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Medical Subject Heading (MeSH) Categories for 207342
Suppliers and Packaging for NDA: 207342
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 207342 | ANDA | Walgreens | 0363-0832 | 0363-0832-14 | 14 BLISTER PACK in 1 CARTON (0363-0832-14) / 1 TABLET in 1 BLISTER PACK |
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 207342 | ANDA | Walgreens | 0363-0832 | 0363-0832-28 | 28 BLISTER PACK in 1 CARTON (0363-0832-28) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
Approval Date: | Jul 11, 2018 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.2GM | ||||
Approval Date: | Jul 11, 2018 | TE: | RLD: | No |
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