Details for New Drug Application (NDA): 214407
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The generic ingredient in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE 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 214407
Tradename: | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE |
Applicant: | L Perrigo Co |
Ingredient: | guaifenesin; pseudoephedrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 214407
Mechanism of Action | Adrenergic alpha-Agonists |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Suppliers and Packaging for NDA: 214407
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 214407 | ANDA | Walgreen Company | 0363-2389 | 0363-2389-62 | 4 BLISTER PACK in 1 CARTON (0363-2389-62) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 214407 | ANDA | Walgreen Company | 0363-8708 | 0363-8708-68 | 2 BLISTER PACK in 1 CARTON (0363-8708-68) / 18 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;60MG | ||||
Approval Date: | Feb 1, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.2GM;120MG | ||||
Approval Date: | Feb 1, 2022 | TE: | RLD: | No |
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