Details for New Drug Application (NDA): 216082
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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 suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
Summary for 216082
Tradename: | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE |
Applicant: | Granules |
Ingredient: | guaifenesin; pseudoephedrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 216082
Mechanism of Action | Adrenergic alpha-Agonists |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Suppliers and Packaging for NDA: 216082
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 | 216082 | ANDA | Granules India Ltd | 62207-827 | 62207-827-72 | 9 BLISTER PACK in 1 CARTON (62207-827-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216082 | ANDA | Granules India Ltd | 62207-828 | 62207-828-71 | 7 BLISTER PACK in 1 CARTON (62207-828-71) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG;60MG | ||||
Approval Date: | Aug 22, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.2GM;120MG | ||||
Approval Date: | Aug 22, 2022 | TE: | RLD: | No |
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