Application 019032

Type: NDA
Sponsor: PROMIUS PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TENEX	GUANFACINE HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE	Yes	No
002	TENEX	GUANFACINE HYDROCHLORIDE	TABLET;ORAL	EQ 2MG BASE	Yes	No
003	TENEX	GUANFACINE HYDROCHLORIDE	TABLET;ORAL	EQ 3MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019032-001	TENEX	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-10-27
N019032-002	TENEX	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-11-07
N019032-003	TENEX	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1988-11-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N019032-001	TENEX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-10-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N019032-002	TENEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-11-07	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N019032-003	TENEX	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1988-11-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019032-001	TENEX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-10-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N019032-002	TENEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-11-07	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N019032-003	TENEX	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1988-11-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019032-001	TENEX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-10-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019032-002	TENEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-11-07	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019032-003	TENEX	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1988-11-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019032-001	TENEX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-10-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019032-002	TENEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-11-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019032-003	TENEX	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1988-11-07	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	REMEDYREPACK INC.	1b1063ba-fee3-4540-9139-db4b915f82e2	2026-04-10	Adverse reactions	Name fallback generic name: GUANFACINE HYDROCHLORIDE
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	American Health Packaging	c38bf26f-8a98-4baa-9abb-c83f812900a1	2024-08-29	Adverse reactions	Name fallback generic name: GUANFACINE HYDROCHLORIDE
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	NORTHSTAR RX LLC	83d0739b-46fd-6228-e85c-089611067a35	2024-07-15	Adverse reactions	Name fallback generic name: GUANFACINE HYDROCHLORIDE
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	XIROMED, LLC	4f1e668a-37dd-44f4-ae99-3a1f6dba3eea	2024-02-24	Adverse reactions	Name fallback generic name: GUANFACINE HYDROCHLORIDE
GUANFACINE	GUANFACINE HYDROCHLORIDE	Aurobindo Pharma Limited	e6d4fc3d-4169-44f1-bcb9-1188de40d4e5	2023-08-08	Adverse reactions	Name fallback generic name: GUANFACINE HYDROCHLORIDE
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	14146031-8d56-469b-8de8-fe3cf1712e78	2021-03-30	Adverse reactions	Name fallback generic name: GUANFACINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67857-705	TENEX	guanfacine hydrochloride	Promius Pharma, LLC	NDA	Current
67857-706	TENEX	guanfacine hydrochloride	Promius Pharma, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57627	ORIG	2019-02-15
33691	SUPPL	2013-07-05
16179	SUPPL	2013-07-05
40862	SUPPL	2002-05-30
20198	SUPPL	2002-05-30
16178	SUPPL	2002-03-12
1209	SUPPL	2002-03-12