Details for New Drug Application (NDA): 075153
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NDA 075153 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 075153
| Tradename: | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Applicant: | L Perrigo Co |
| Ingredient: | pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 075153
| Mechanism of Action | Adrenergic alpha-Agonists |
Suppliers and Packaging for NDA: 075153
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 075153 | ANDA | L. Perrigo Company | 0113-0054 | 0113-0054-52 | 10 BLISTER PACK in 1 CARTON (0113-0054-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| PSEUDOEPHEDRINE HYDROCHLORIDE | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 075153 | ANDA | Walgreen Company | 0363-0061 | 0363-0061-52 | 10 BLISTER PACK in 1 CARTON (0363-0061-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Feb 26, 1999 | TE: | RLD: | No | |||||
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