Details for New Drug Application (NDA): 216082
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NDA 216082 describes GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, Dr Reddys, Granules, L Perrigo Co, and Sun Pharm Inds Inc, and is included in six NDAs. It is available from twenty-eight suppliers. Additional details are available on the GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.
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.
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 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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