Application 207169

Type: ANDA
Sponsor: PAR PHARM 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
A207169-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29
A207169-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29
A207169-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207169-001	AB
A207169-002	AB
A207169-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`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	A207169-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207169-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207169-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207169-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207169-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207169-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207169-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207169-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207169-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207169-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207169-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207169-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207169-001	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	Endo USA, Inc.	863f12bd-d4a9-4547-8667-5dfa9e2ce6d1	2024-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207169 application number: ANDA207169 ndc (product): 49884-874 ndc (product): 49884-814 ndc (product): 49884-849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	17b24a0b-03e4-4b58-87ab-3d66fec30226	2023-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207169 application number: ANDA207169
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	5a6705af-bb72-4edb-863a-93a351bd6dba	2023-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207169 application number: ANDA207169 ndc (product): 63629-2227

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
49884-814	Midodrine Hydrochloride	Midodrine Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-849	Midodrine Hydrochloride	Midodrine Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-874	Midodrine Hydrochloride	Midodrine Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
63629-2227	Midodrine Hydrochloride	Midodrine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2227	Midodrine Hydrochloride	Midodrine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7983	Midodrine Hydrochloride	Midodrine Hydrochloride	Bryant Ranch Prepack	ANDA	Current