Application 207849

Type: ANDA
Sponsor: CEROVENE 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
A207849-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01
A207849-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01
A207849-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207849-001	AB
A207849-002	AB
A207849-003	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 3 · 114 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	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A207849-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207849-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207849-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207849-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207849-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207849-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207849-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207849-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207849-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207849-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207849-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207849-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207849-001	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 · 9 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	78446de1-81f6-4764-98f3-44b4057f2175	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	572edc14-3450-46db-bec6-9d63e620a364	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	9c1ccd24-3f9c-489c-9fd2-98e69531d5ab	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	6498f9ab-3345-4343-918e-9c5014d6dd80	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849 ndc (product): 63629-2348
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	df43f108-c89c-49e7-9c1a-77a0ce9b03b5	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849 ndc (product): 63629-2346
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	7ec8fb86-18c4-4751-87e4-ca1e9e885088	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849 ndc (product): 63629-2347
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	c4d0b757-bb6e-4df4-e053-2995a90a3042	2023-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849 ndc (product): 51407-389 ndc (product): 51407-390 ndc (product): 51407-388
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Proficient Rx LP	0aebf5f9-8cfa-4b77-ba40-821ce0a2b266	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849 ndc (product): 71205-905 ndc (product): 71205-906 ndc (product): 71205-904
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Xiromed, LLC	a4332a41-2a0a-a14a-9ce5-1465f39ff725	2020-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849 ndc (product): 70700-158 ndc (product): 70700-157 ndc (product): 70700-159

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-388	Midodrine Hydrochloride	midodrine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-388	Midodrine Hydrochloride	midodrine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-389	Midodrine Hydrochloride	midodrine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-389	Midodrine Hydrochloride	midodrine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-390	Midodrine Hydrochloride	midodrine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-390	Midodrine Hydrochloride	midodrine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
63629-2346	Midodrine Hydrochloride	midodrine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2346	Midodrine Hydrochloride	midodrine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2347	Midodrine Hydrochloride	midodrine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2347	Midodrine Hydrochloride	midodrine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2348	Midodrine Hydrochloride	midodrine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2348	Midodrine Hydrochloride	midodrine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63739-145	Midodrine Hydrochloride	midodrine hydrochloride	McKesson Corporation DBA SKY Packaging	ANDA	Current
70700-157	Midodrine Hydrochloride	midodrine hydrochloride	Xiromed, LLC	ANDA	Current
70700-157	Midodrine Hydrochloride	midodrine hydrochloride	Xiromed, LLC	ANDA	Current
70700-157	Midodrine Hydrochloride	midodrine hydrochloride	Xiromed, LLC	ANDA	Current
70700-158	Midodrine Hydrochloride	midodrine hydrochloride	Xiromed, LLC	ANDA	Current
70700-158	Midodrine Hydrochloride	midodrine hydrochloride	Xiromed, LLC	ANDA	Current
70700-158	Midodrine Hydrochloride	midodrine hydrochloride	Xiromed, LLC	ANDA	Current
70700-159	Midodrine Hydrochloride	midodrine hydrochloride	Xiromed, LLC	ANDA	Current
70700-159	Midodrine Hydrochloride	midodrine hydrochloride	Xiromed, LLC	ANDA	Current
70700-159	Midodrine Hydrochloride	midodrine hydrochloride	Xiromed, LLC	ANDA	Current
71205-904	Midodrine Hydrochloride	midodrine hydrochloride	Proficient Rx LP	ANDA	Current
71205-904	Midodrine Hydrochloride	midodrine hydrochloride	Proficient Rx LP	ANDA	Current
71205-905	Midodrine Hydrochloride	midodrine hydrochloride	Proficient Rx LP	ANDA	Current
71205-905	Midodrine Hydrochloride	midodrine hydrochloride	Proficient Rx LP	ANDA	Current
71205-906	Midodrine Hydrochloride	midodrine hydrochloride	Proficient Rx LP	ANDA	Current
71205-906	Midodrine Hydrochloride	midodrine hydrochloride	Proficient Rx LP	ANDA	Current