Details for New Drug Application (NDA): 209008
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NDA 209008 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 209008
| Tradename: | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 209008
| Mechanism of Action | Adrenergic alpha-Agonists |
Suppliers and Packaging for NDA: 209008
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209008 | ANDA | Better Living Brands LLC | 21130-158 | 21130-158-67 | 2 BLISTER PACK in 1 CARTON (21130-158-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| PSEUDOEPHEDRINE HYDROCHLORIDE | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209008 | ANDA | Aurohealth LLC | 58602-804 | 58602-804-67 | 2 BLISTER PACK in 1 CARTON (58602-804-67) / 10 TABLET, 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: | Jun 9, 2017 | TE: | RLD: | No | |||||
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