Application 019815

Type: NDA
Sponsor: SHIRE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROAMATINE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	PROAMATINE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	PROAMATINE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N019815-001	PROAMATINE	MIDODRINE HYDROCHLORIDE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06
N019815-002	PROAMATINE	MIDODRINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06
N019815-003	PROAMATINE	MIDODRINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20

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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019815-002	PROAMATINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019815-003	PROAMATINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`8072bd15b7f6…`

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 3 · 51 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	NorthStar RxLLC	79b712a3-be12-4ea6-ac42-742826685ae5	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	American Health Packaging	159cb0cb-4b27-4a1c-8ad4-dc93604c79c7	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	54ded041-c78c-4646-a1cc-c94afcd62690	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5c83cb11-0920-4049-bd6d-c9df0d8a5423	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	52952ca6-bbce-4755-b73e-76a65f00a6bc	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Avet Pharmaceuticals Inc.	4d5e42be-3476-85d4-e063-6294a90a0865	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Safecor Health LLC	6ab70071-e733-44e2-bcc3-f08227901b29	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	AvKARE	1c2e8707-550f-430f-87f3-4bb3d55f4aba	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Advagen Pharma Limited	8cf90a48-d4a1-4099-b6e1-52d2eaaad1bb	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Novugen Pharma (USA) LLC	2bf011fe-d114-42a4-93e2-76a993a3ba34	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	78d447cb-e3ff-433b-9758-b907a75b0666	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Cardinal Health 107, LLC	5e2443c2-f714-4b1d-bf2d-22742f411961	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	679b72bd-f50e-4075-a531-99372b5a4fac	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	dc03ebb7-f4cc-451a-927d-f8bfb6a3c805	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	db4b18d6-68f9-4d7c-9230-40b928cf859c	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Cardinal Health 107, LLC	66bccee4-b466-4fe9-89d6-8c9eaaa92413	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Cardinal Health 107, LLC	24847065-0be0-46eb-a084-7e5425a8be73	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	First Nation Group, LLC	414cebaa-b87f-4d41-bc41-a77dcd3ea434	2025-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Mylan Institutional Inc.	fd28d383-add9-42a9-ad07-4d7e89f12460	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Upsher-Smith laboratories, LLC	4c3517f3-1c68-4ade-b5f1-c488a3a335c1	2025-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47236	SUPPL	2017-02-16
47135	SUPPL	2017-02-08
19255	SUPPL	2004-07-28
41043	SUPPL	2002-03-20
1643	SUPPL	2002-03-20
57443	ORIG	1996-09-06