Details for New Drug Application (NDA): 077442
✉ Email this page to a colleague
NDA 077442 describes PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, L Perrigo Co, Sun Pharm Inds Ltd, Cent Pharms, Graham Dm, Kv Pharm, and Sandoz, and is included in eight NDAs. It is available from thirty-one suppliers. Additional details are available on the PSEUDOEPHEDRINE HYDROCHLORIDE profile page.
The generic ingredient in PSEUDOEPHEDRINE HYDROCHLORIDE is pseudoephedrine hydrochloride; triprolidine hydrochloride. There are forty-nine drug master file entries for this compound. Additional details are available on the pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.
The generic ingredient in PSEUDOEPHEDRINE HYDROCHLORIDE is pseudoephedrine hydrochloride; triprolidine hydrochloride. There are forty-nine drug master file entries for this compound. Additional details are available on the pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.
Summary for 077442
| Tradename: | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Applicant: | Sun Pharm Inds Ltd |
| Ingredient: | pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 077442
| Mechanism of Action | Adrenergic alpha-Agonists |
Suppliers and Packaging for NDA: 077442
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 077442 | ANDA | Walgreen Company | 0363-0204 | 0363-0204-20 | 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-20) |
| PSEUDOEPHEDRINE HYDROCHLORIDE | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 077442 | ANDA | Walgreen Company | 0363-0204 | 0363-0204-69 | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-69) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Sep 28, 2005 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
