Application 071839

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	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071839-001	MINOXIDIL	MINOXIDIL	10MG	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
A071839-001	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	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071839-001	MINOXIDIL	10MG	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	A071839-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071839-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071839-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071839-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071839-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071839-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071839-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071839-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071839-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071839-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071839-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071839-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071839-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071839-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071839-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071839-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071839-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071839-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071839-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071839-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071839-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071839-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071839-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071839-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071839-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071839-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071839-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071839-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071839-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071839-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071839-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071839-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071839-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071839-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071839-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071839-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071839-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071839-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071839-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071839-001	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	665cba3d-5f26-468a-a047-188a413fbede	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	b138c404-028c-4a73-a127-c96f2072e1f8	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839 ndc (product): 63629-9299
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	e39469e6-d4f6-450f-872c-6f538e67c71a	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	934508f8-9252-4d48-ae91-0ce96454dc7b	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839 ndc (product): 63629-2231
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): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	Par Health USA, LLC	8f3800f0-b6da-4dfe-8c32-39bb5eb0262a	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839 ndc (product): 49884-257
Minoxidil	MINOXIDIL	American Health Packaging	0b4fc036-9497-442b-b629-c4b386932789	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839 ndc (product): 68084-205
Minoxidil	MINOXIDIL	A-S Medication Solutions	f00f3370-0313-4ce0-be7d-80db4477d9ae	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	6277d0dc-ac63-4393-a8ef-5350d9808876	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839 ndc (product): 63629-2230

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
49884-257	Minoxidil	Minoxidil	Par Pharmaceutical, Inc.	ANDA	Current
53808-0733	MINOXIDIL	minoxidil	DOH CENTRAL PHARMACY	ANDA	Current
53808-1032	Minoxidil	Minoxidil	State of Florida DOH Central Pharmacy	ANDA	Current
63629-2230	Minoxidil	Minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-2230	Minoxidil	Minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-2231	Minoxidil	Minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-2231	Minoxidil	Minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-9299	Minoxidil	Minoxidil	Bryant Ranch Prepack	ANDA	Current
68084-205	Minoxidil	Minoxidil	American Health Packaging	ANDA	Current
68084-205	Minoxidil	Minoxidil	American Health Packaging	ANDA	Current
68084-205	Minoxidil	Minoxidil	American Health Packaging	ANDA	Current
68084-205	Minoxidil	Minoxidil	American Health Packaging	ANDA	Current