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MIDODRINE HYDROCHLORIDE	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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PROAMATINE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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PROAMATINE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 43.

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PROAMATINE	MIDODRINE HYDROCHLORIDE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06
N019815-002	PROAMATINE	MIDODRINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06
N019815-003	PROAMATINE	MIDODRINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-03-20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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019815-001	PROAMATINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

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 2 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Major Pharmaceuticals	164dce3b-1927-497e-884a-a2c72958beb9	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	ffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	NorthStar Rx LLC	b015c98f-57e6-410b-9c9d-8898aa22082a	2025-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	AvPAK	9106776e-601a-4e3c-e053-2995a90a5435	2025-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Umasuto, LLC	4f5e1689-9691-471b-a39c-26120d6ce073	2025-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Coupler LLC	2d1b58a7-ec7f-f3ea-e063-6294a90a27fb	2025-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	c41f7ec2-a3d7-4ff0-b51d-feda49717e7b	2024-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	6c089bcf-c3ac-44c3-9336-8358c4d81bcd	2024-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine hydrochloride	MIDODRINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	3bc97210-fa2f-4979-abdf-d92e5973e6e3	2024-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	78446de1-81f6-4764-98f3-44b4057f2175	2024-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	572edc14-3450-46db-bec6-9d63e620a364	2024-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	9c1ccd24-3f9c-489c-9fd2-98e69531d5ab	2024-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Aurobindo Pharma Limited	771b3e81-f15b-4d32-a1d8-c43b104d1f7b	2024-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	6498f9ab-3345-4343-918e-9c5014d6dd80	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	df43f108-c89c-49e7-9c1a-77a0ce9b03b5	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	7ec8fb86-18c4-4751-87e4-ca1e9e885088	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Lifestar Pharma LLC	99d4aa03-81f7-4b43-a7b4-4ecc5ad13304	2023-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine hydrochloride	MIDODRINE HYDROCHLORIDE	Zydus Lifesciences Limited	b4c4417e-d8fd-46c8-b82f-ffbc8f201752	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	c4d0b757-bb6e-4df4-e053-2995a90a3042	2023-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDODRINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

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