Details for New Drug Application (NDA): 202238
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NDA 202238 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 202238
| Tradename: | GUANFACINE HYDROCHLORIDE |
| Applicant: | Impax Labs Inc |
| Ingredient: | guanfacine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 202238
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Oct 20, 2015 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Oct 20, 2015 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 3MG BASE | ||||
| Approval Date: | Oct 20, 2015 | TE: | RLD: | No | |||||
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