Details for New Drug Application (NDA): 078912
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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 078912
Tradename: | GUAIFENESIN |
Applicant: | Perrigo R And D |
Ingredient: | guaifenesin |
Patents: | 0 |
Pharmacology for NDA: 078912
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Medical Subject Heading (MeSH) Categories for 078912
Suppliers and Packaging for NDA: 078912
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 078912 | ANDA | L. Perrigo Company | 0113-2023 | 0113-2023-60 | 1 BOTTLE in 1 CARTON (0113-2023-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE |
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 078912 | ANDA | Target Corporation | 11673-421 | 11673-421-60 | 1 BOTTLE in 1 CARTON (11673-421-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
Approval Date: | Nov 23, 2011 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.2GM | ||||
Approval Date: | Nov 5, 2020 | TE: | RLD: | No |
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