Details for New Drug Application (NDA): 074673
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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 074673
Tradename: | GUANFACINE HYDROCHLORIDE |
Applicant: | Epic Pharma Llc |
Ingredient: | guanfacine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 074673
Mechanism of Action | Adrenergic alpha2-Agonists |
Medical Subject Heading (MeSH) Categories for 074673
Suppliers and Packaging for NDA: 074673
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 074673 | ANDA | Major Pharmaceuticals | 0904-7140 | 0904-7140-04 | 30 BLISTER PACK in 1 CARTON (0904-7140-04) / 1 TABLET in 1 BLISTER PACK |
GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 074673 | ANDA | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-730 | 24658-730-01 | 100 TABLET in 1 BOTTLE (24658-730-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Feb 28, 1997 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Feb 28, 1997 | TE: | AB | RLD: | No |
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