Application 076577

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A076577-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10
A076577-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10
A076577-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076577-001	AB
A076577-002	AB
A076577-003	AB

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076577-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2003-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076577-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2003-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076577-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2003-09-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076577-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076577-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076577-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076577-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076577-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076577-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076577-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076577-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076577-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076577-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076577-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076577-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076577-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076577-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076577-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076577-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076577-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076577-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076577-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076577-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076577-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076577-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076577-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076577-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076577-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076577-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076577-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076577-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076577-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076577-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076577-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076577-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076577-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076577-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076577-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076577-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076577-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076577-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076577-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076577-001	AB	1	`1e350fbaab3a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Safecor Health LLC	6ab70071-e733-44e2-bcc3-f08227901b29	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076577 application number: ANDA076577
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Cardinal Health 107, LLC	66bccee4-b466-4fe9-89d6-8c9eaaa92413	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076577 application number: ANDA076577 ndc (product): 55154-5696
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Mylan Institutional Inc.	fd28d383-add9-42a9-ad07-4d7e89f12460	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076577 application number: ANDA076577 ndc (product): 51079-453
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	32fad00b-7e7b-4d35-9e8b-fdc979fdb88e	2022-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076577 application number: ANDA076577 ndc (product): 0378-1903 ndc (product): 0378-1902 ndc (product): 0378-1901

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1901	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1901	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1901	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1901	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1901	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1902	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1902	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1902	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1902	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1902	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1903	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1903	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1903	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1903	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1903	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-5647	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7559	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7566	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
51079-453	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-453	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-453	Midodrine Hydrochloride	midodrine hydrochloride	Mylan Institutional Inc.	ANDA	Current
55154-5696	Midodrine Hydrochloride	Midodrine Hydrochloride	Cardinal Health	ANDA	Current
55154-5696	Midodrine Hydrochloride	Midodrine Hydrochloride	Cardinal Health	ANDA	Current
55154-5696	Midodrine Hydrochloride	Midodrine Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-5696	Midodrine Hydrochloride	Midodrine Hydrochloride	Cardinal Health	ANDA	Current
63629-6928	Midodrine Hydrochloride	midodrine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6928	Midodrine Hydrochloride	midodrine hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43089	ORIG	2005-07-22