Details for New Drug Application (NDA): 213420
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NDA 213420 describes GUAIFENESIN, which is a drug marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Granules, Guardian Drug, Marksans Pharma, Ohm Labs Inc, Perrigo R And D, Sun Pharm, Aurobindo Pharma Ltd, L Perrigo Co, and Sun Pharm Inds Inc, and is included in twenty-one NDAs. It is available from seventy-nine suppliers. Additional details are available on the GUAIFENESIN profile page.
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.
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 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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