Details for New Drug Application (NDA): 218326
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NDA 218326 describes GUANFACINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic, Apotex, Impax Labs Inc, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms Usa, Twi Pharms, Wanbang Biopharms, Yichang Humanwell, Ajanta Pharma Ltd, Amneal Pharm, Aurobindo Pharma Usa, Epic Pharma Llc, I 3 Pharms, Rubicon, Unichem, Watson Labs, and Xiromed, and is included in twenty-two NDAs. It is available from thirty-three suppliers. Additional details are available on the GUANFACINE HYDROCHLORIDE profile page.
The generic ingredient in GUANFACINE HYDROCHLORIDE is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.
The generic ingredient in GUANFACINE HYDROCHLORIDE is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.
Summary for 218326
| Tradename: | GUANFACINE HYDROCHLORIDE |
| Applicant: | Xiromed |
| Ingredient: | guanfacine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218326
| Mechanism of Action | Adrenergic alpha2-Agonists |
Medical Subject Heading (MeSH) Categories for 218326
Suppliers and Packaging for NDA: 218326
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 218326 | ANDA | XIROMED, LLC | 70700-301 | 70700-301-01 | 100 TABLET in 1 BOTTLE (70700-301-01) |
| GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 218326 | ANDA | XIROMED, LLC | 70700-301 | 70700-301-30 | 30 TABLET in 1 BOTTLE (70700-301-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Feb 23, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Feb 23, 2024 | TE: | AB | RLD: | No | ||||
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