Application 208092

Type: ANDA
Sponsor: P AND L

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOXIDIL (FOR MEN)	MINOXIDIL	AEROSOL, FOAM;TOPICAL	5%	No	No
002	MINOXIDIL (FOR WOMEN)	MINOXIDIL	AEROSOL, FOAM;TOPICAL	5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208092-001	MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2017-02-17
A208092-002	MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2017-07-27

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208092-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2017-02-17	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208092-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2017-07-27	`3a93d1ddd44b…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	Keranique	4af782f4-68d5-4338-a0a6-85d11a23ce98	2026-08-18	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	869ce741-3094-4123-9059-0669f3591b2f	2026-08-06	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil For Women	MINOXIDIL	BosleyMD	ebda6e49-140c-4ab0-b155-5ed501ef3e8a	2026-03-24	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil For Men	MINOXIDIL	BosleyMD	61c41686-81af-4000-94bc-3cf9e71b0f18	2026-03-24	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	204bab15-47c5-449c-a889-700914b04b61	2026-03-03	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	04373c29-85f3-4d7d-bbdd-950dcf1a879a	2026-03-03	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	59e7cdae-6595-4aa2-8fe0-7a8bcf300912	2024-11-05	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092
Minoxidil	MINOXIDIL	P & L Development, LLC	73dc7e7f-92c2-4ab2-a260-ceb198e591cf	2024-11-05	Warnings	Exact identifier application applno (ANDA): 208092 application number: ANDA208092

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0472-1660	minoxidil	minoxidil	Actavis Pharma, Inc.	ANDA	Current
0472-1660	minoxidil	minoxidil	Actavis Pharma, Inc.	ANDA	Current
0472-1665	minoxidil	minoxidil	Actavis Pharma, Inc.	ANDA	Current
0472-1665	minoxidil	minoxidil	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49130	ORIG	2017-07-28