Application 213055

Type: ANDA
Sponsor: ZYDUS

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
A213055-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01
A213055-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01
A213055-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213055-001	AB
A213055-002	AB
A213055-003	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	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213055-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-09-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213055-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213055-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-09-01	`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	A213055-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213055-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213055-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213055-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213055-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213055-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213055-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213055-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213055-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213055-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213055-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213055-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213055-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213055-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213055-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213055-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213055-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213055-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213055-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213055-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213055-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213055-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213055-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213055-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213055-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213055-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213055-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213055-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213055-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213055-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213055-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213055-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213055-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213055-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213055-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213055-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213055-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213055-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213055-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213055-001	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	Zydus Pharmaceuticals (USA) Inc.	3bc97210-fa2f-4979-abdf-d92e5973e6e3	2024-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213055 application number: ANDA213055 ndc (product): 68382-739 ndc (product): 68382-737 ndc (product): 68382-738
Midodrine hydrochloride	MIDODRINE HYDROCHLORIDE	Zydus Lifesciences Limited	b4c4417e-d8fd-46c8-b82f-ffbc8f201752	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213055 application number: ANDA213055 ndc (product): 70771-1597 ndc (product): 70771-1595 ndc (product): 70771-1596

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-737	Midodrine hydrochloride	Midodrine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-738	Midodrine hydrochloride	Midodrine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-739	Midodrine hydrochloride	Midodrine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1595	Midodrine hydrochloride	Midodrine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1596	Midodrine hydrochloride	Midodrine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1597	Midodrine hydrochloride	Midodrine hydrochloride	Cadila Healthcare Limited	ANDA	Current