Application 214734

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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
A214734-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21
A214734-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21
A214734-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214734-001	AB
A214734-002	AB
A214734-003	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 · 108 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	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214734-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214734-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214734-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-21	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A214734-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214734-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214734-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214734-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214734-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214734-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214734-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214734-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214734-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214734-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214734-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214734-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214734-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214734-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214734-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214734-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214734-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214734-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214734-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214734-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214734-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214734-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214734-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214734-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214734-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214734-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214734-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214734-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214734-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214734-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214734-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214734-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214734-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214734-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214734-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214734-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214734-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214734-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214734-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214734-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	03b54024-2a26-4abe-bd8b-b66bb6781fa7	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214734 application number: ANDA214734 ndc (product): 46708-339 ndc (product): 46708-340 ndc (product): 46708-338
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	873c8e29-6961-4648-bfc8-f91c2086bd94	2021-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214734 application number: ANDA214734 ndc (product): 62332-340 ndc (product): 62332-338 ndc (product): 62332-339

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
0615-8443	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8444	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8445	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
46708-338	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-339	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-340	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
62332-338	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-338	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-339	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-339	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-340	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-340	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current