Details for New Drug Application (NDA): 091071
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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 091071
Tradename: | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE |
Applicant: | Actavis Labs Fl |
Ingredient: | guaifenesin; pseudoephedrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 091071
Mechanism of Action | Adrenergic alpha-Agonists |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Suppliers and Packaging for NDA: 091071
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 | 091071 | ANDA | H E B | 37808-777 | 37808-777-68 | 36 BLISTER PACK in 1 CARTON (37808-777-68) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091071 | ANDA | H E B | 37808-777 | 37808-777-89 | 18 BLISTER PACK in 1 CARTON (37808-777-89) / 1 TABLET, 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: | May 27, 2015 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.2GM;120MG | ||||
Approval Date: | May 27, 2015 | TE: | RLD: | No |
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