Application 076725

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORVATEN	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
002	ORVATEN	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	Yes
003	ORVATEN	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	RLD / RS	Approval date
A076725-001	ORVATEN	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		2004-11-03
A076725-002	ORVATEN	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	2004-11-03
A076725-003	ORVATEN	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2004-11-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076725-001	AB
A076725-002	AB
A076725-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076725-002	ORVATEN	5MG	TABLET / ORAL	AB	RS	2004-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076725-003	ORVATEN	10MG	TABLET / ORAL	AB		2004-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076725-001	ORVATEN	2.5MG	TABLET / ORAL	AB		2004-11-03	`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	A076725-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076725-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076725-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076725-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076725-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076725-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076725-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076725-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076725-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076725-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076725-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076725-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076725-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076725-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076725-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076725-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076725-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076725-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076725-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076725-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076725-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076725-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076725-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076725-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076725-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076725-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076725-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076725-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076725-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076725-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076725-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076725-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076725-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076725-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076725-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076725-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076725-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076725-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076725-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076725-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Avet Pharmaceuticals Inc.	4d5e42be-3476-85d4-e063-6294a90a0865	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076725 application number: ANDA076725
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Cardinal Health 107, LLC	24847065-0be0-46eb-a084-7e5425a8be73	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076725 application number: ANDA076725 ndc (product): 55154-5623
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Upsher-Smith laboratories, LLC	4c3517f3-1c68-4ade-b5f1-c488a3a335c1	2025-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076725 application number: ANDA076725 ndc (product): 0245-0211 ndc (product): 0245-0213 ndc (product): 0245-0212

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0245-0211	Midodrine Hydrochloride	midodrine hydrochloride	Upsher-Smith laboratories, LLC	ANDA	Current
0245-0211	Midodrine Hydrochloride	midodrine hydrochloride	Upsher-Smith laboratories, LLC	ANDA	Current
0245-0211	Midodrine Hydrochloride	midodrine hydrochloride	Upsher-Smith laboratories, LLC	ANDA	Current
0245-0212	Midodrine Hydrochloride	midodrine hydrochloride	Upsher-Smith laboratories, LLC	ANDA	Current
0245-0212	Midodrine Hydrochloride	midodrine hydrochloride	Upsher-Smith laboratories, LLC	ANDA	Current
0245-0212	Midodrine Hydrochloride	midodrine hydrochloride	Upsher-Smith laboratories, LLC	ANDA	Current
0245-0213	Midodrine Hydrochloride	midodrine hydrochloride	Upsher-Smith laboratories, LLC	ANDA	Current
0245-0213	Midodrine Hydrochloride	midodrine hydrochloride	Upsher-Smith laboratories, LLC	ANDA	Current
0245-0213	Midodrine Hydrochloride	midodrine hydrochloride	Upsher-Smith laboratories, LLC	ANDA	Current
55154-5623	Midodrine HCl	midodrine hydrochloride	Cardinal Health	ANDA	Current
55154-5623	Midodrine HCl	midodrine hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-5623	Midodrine HCl	midodrine hydrochloride	Cardinal Health	ANDA	Current