Details for New Drug Application (NDA): 075109
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The generic ingredient in GUANFACINE HYDROCHLORIDE is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.
Summary for 075109
Tradename: | GUANFACINE HYDROCHLORIDE |
Applicant: | Amneal Pharm |
Ingredient: | guanfacine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 075109
Mechanism of Action | Adrenergic alpha2-Agonists |
Medical Subject Heading (MeSH) Categories for 075109
Suppliers and Packaging for NDA: 075109
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 075109 | ANDA | A-S Medication Solutions | 50090-6073 | 50090-6073-0 | 30 TABLET in 1 BOTTLE (50090-6073-0) |
GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 075109 | ANDA | AvPAK | 50268-374 | 50268-374-15 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-374-15) / 1 TABLET in 1 BLISTER PACK (50268-374-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Nov 25, 1998 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Nov 25, 1998 | TE: | AB | RLD: | No |
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