Application 071826

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOXIDIL	MINOXIDIL	TABLET;ORAL	2.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071826-001	MINOXIDIL	MINOXIDIL	2.5MG	TABLET / ORAL	AB		1988-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071826-001	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 2 · 42 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	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A071826-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071826-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071826-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071826-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071826-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071826-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071826-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071826-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071826-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071826-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071826-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071826-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071826-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071826-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071826-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071826-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071826-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071826-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071826-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071826-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071826-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071826-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071826-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071826-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071826-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071826-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071826-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071826-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071826-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071826-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071826-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071826-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071826-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071826-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071826-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071826-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071826-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071826-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071826-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071826-001	AB	1	`e64feba35796…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	Preferred Pharmaceuticals Inc.	cdfd3330-4836-4655-80a2-441380529a67	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826 ndc (product): 68788-8273
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	75b2832c-0a6c-4125-9514-19a6d8dbf6cf	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826 ndc (product): 63629-9433
Minoxidil	MINOXIDIL	Golden State Medical Supply, Inc.	1d134237-3e94-258e-e063-6294a90af556	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	Par Health USA, LLC	8f3800f0-b6da-4dfe-8c32-39bb5eb0262a	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826 ndc (product): 49884-256
Minoxidil	MINOXIDIL	NuCare Pharmaceuticals, Inc.	2e5a2976-06fb-43f9-e063-6294a90a3bf5	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	American Health Packaging	0b4fc036-9497-442b-b629-c4b386932789	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826 ndc (product): 68084-204
Minoxidil	MINOXIDIL	A-S Medication Solutions	6c85c69e-b5af-4e98-aacf-f65ad15d00d7	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	Proficient Rx LP	a0066eac-cb58-49ef-a480-105cb1043c2b	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	b18e42ee-e5fa-441f-a6b6-1eb17836d668	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826 ndc (product): 63629-2232
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	7aa8d272-0e44-43df-9263-9d84b2aa8946	2024-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7593	Minoxidil	Minoxidil	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
49884-256	Minoxidil	Minoxidil	Par Pharmaceutical, Inc.	ANDA	Current
63629-2232	Minoxidil	Minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-2232	Minoxidil	Minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-2232	Minoxidil	Minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-9433	Minoxidil	Minoxidil	Bryant Ranch Prepack	ANDA	Current
68084-204	Minoxidil	Minoxidil	American Health Packaging	ANDA	Current
68084-204	Minoxidil	Minoxidil	American Health Packaging	ANDA	Current
68084-204	Minoxidil	Minoxidil	American Health Packaging	ANDA	Current
68084-204	Minoxidil	Minoxidil	American Health Packaging	ANDA	Current
68788-8273	Minoxidil	Minoxidil	Preferred Pharmaceuticals Inc.	ANDA	Current