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 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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