Application 076514

Type: ANDA
Sponsor: CHARTWELL RX

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 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	Approval date
A076514-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11
A076514-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11
A076514-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`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 3 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	Bryant Ranch Prepack	17b24a0b-03e4-4b58-87ab-3d66fec30226	2023-10-06	Warnings, Adverse reactions	Name fallback brand name: Midodrine Hydrochloride generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	60d5a132-9cfc-48e2-aa71-1949aeb255c3	2023-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midodrine Hydrochloride generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	5a6705af-bb72-4edb-863a-93a351bd6dba	2023-02-27	Warnings, Adverse reactions	Name fallback brand name: Midodrine Hydrochloride generic name: MIDODRINE HYDROCHLORIDE
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	03b54024-2a26-4abe-bd8b-b66bb6781fa7	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MIDODRINE HYDROCHLORIDE generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	32fad00b-7e7b-4d35-9e8b-fdc979fdb88e	2022-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midodrine Hydrochloride generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Proficient Rx LP	0aebf5f9-8cfa-4b77-ba40-821ce0a2b266	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midodrine Hydrochloride generic name: MIDODRINE HYDROCHLORIDE
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	873c8e29-6961-4648-bfc8-f91c2086bd94	2021-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MIDODRINE HYDROCHLORIDE generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	TruPharma, LLC	a88cd5b5-bdcb-4ef7-8b04-ee4603bcd621	2021-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midodrine Hydrochloride generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	2be17e48-8258-4f29-914b-7f0fe9ace7a1	2020-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midodrine Hydrochloride generic name: MIDODRINE HYDROCHLORIDE
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Xiromed, LLC	a4332a41-2a0a-a14a-9ce5-1465f39ff725	2020-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midodrine Hydrochloride generic name: MIDODRINE 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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0040	Midodrine HCl	Midodrine Hydrochloride	Eon Labs, Inc.	ANDA	Current
0185-0043	Midodrine HCl	Midodrine Hydrochloride	Eon Labs, Inc.	ANDA	Current
0185-0149	Midodrine HCl	Midodrine Hydrochloride	Eon Labs, Inc.	ANDA	Current
21695-181	Midodrine HCl	Midodrine Hydrochloride	Rebel Distributors Corp	ANDA	Current
55154-4989	Midodrine HCl	Midodrine Hydrochloride	Cardinal Health	ANDA	Current
55154-6847	Midodrine HCl	Midodrine Hydrochloride	Cardinal Health	ANDA	Current
63739-556	Midodrine HCl	Midodrine Hydrochloride	McKesson Corporation	ANDA	Current
68084-240	Midodrine HCl	Midodrine Hydrochloride	American Health Packaging	ANDA	Current
68084-241	Midodrine HCl	Midodrine Hydrochloride	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43085	SUPPL	2005-07-22
43084	SUPPL	2005-07-22
43083	ORIG	2005-07-22
22568	SUPPL	2005-07-22