Details for New Drug Application (NDA): 213420
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The generic ingredient in GUAIFENESIN is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
Summary for 213420
Tradename: | GUAIFENESIN |
Applicant: | Granules |
Ingredient: | guaifenesin |
Patents: | 0 |
Pharmacology for NDA: 213420
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Medical Subject Heading (MeSH) Categories for 213420
Suppliers and Packaging for NDA: 213420
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 213420 | ANDA | L. Perrigo Company | 0113-3650 | 0113-3650-00 | 1 BLISTER PACK in 1 CARTON (0113-3650-00) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK |
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 213420 | ANDA | L. Perrigo Company | 0113-3650 | 0113-3650-01 | 2 BLISTER PACK in 1 CARTON (0113-3650-01) / 14 TABLET, MULTILAYER, 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: | May 8, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.2GM | ||||
Approval Date: | May 8, 2020 | TE: | RLD: | No |
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