Application 072709

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOXIDIL	MINOXIDIL	TABLET;ORAL	10MG	No	No
002	MINOXIDIL	MINOXIDIL	TABLET;ORAL	2.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A072709-001	MINOXIDIL	MINOXIDIL	10MG	TABLET / ORAL	AB		1995-12-14
A072709-002	MINOXIDIL	MINOXIDIL	2.5MG	TABLET / ORAL	AB		1995-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A072709-001	AB
A072709-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072709-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1995-12-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072709-002	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1995-12-14	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072709-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072709-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072709-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072709-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072709-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072709-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072709-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072709-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072709-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072709-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072709-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072709-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072709-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072709-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072709-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072709-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072709-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072709-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072709-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072709-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072709-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072709-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072709-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072709-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072709-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072709-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072709-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072709-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072709-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072709-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072709-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A072709-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072709-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A072709-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072709-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072709-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072709-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072709-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072709-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072709-002	AB	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MINOXIDIL	MINOXIDIL	PD-Rx Pharmaceuticals, Inc.	5fea137a-bc88-4b24-85db-538c90ad1870	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072709 application number: ANDA072709 ndc (product): 72789-278
MINOXIDIL	MINOXIDIL	PD-Rx Pharmaceuticals, Inc.	f0dae476-8d0b-4d0c-a505-ad51bf27a1c8	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072709 application number: ANDA072709 ndc (product): 72789-279
MINOXIDIL	MINOXIDIL	Sun Pharmaceutical Industries, Inc.	0354a7f5-5917-44dc-9963-411104008cb5	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072709 application number: ANDA072709 ndc (product): 53489-386 ndc (product): 53489-387
MINOXIDIL	MINOXIDIL	AvKARE	02d7399f-94cc-f718-f214-587301edd138	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 42291-619
MINOXIDIL	MINOXIDIL	Bryant Ranch Prepack	40da3ec5-39db-42f1-b0d6-39d852130307	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072709 application number: ANDA072709 ndc (product): 63629-1086

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-619	MINOXIDIL	minoxidil	AvKARE, Inc.	ANDA	Current
42291-619	MINOXIDIL	minoxidil	AvKARE, Inc.	ANDA	Current
42291-619	MINOXIDIL	minoxidil	AvKARE, Inc.	ANDA	Current
42291-619	MINOXIDIL	minoxidil	AvKARE	ANDA	Current
42291-619	MINOXIDIL	minoxidil	AvKARE	ANDA	Current
53489-386	MINOXIDIL	minoxidil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
53489-387	MINOXIDIL	minoxidil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63629-1084	MINOXIDIL	minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-1084	MINOXIDIL	minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-1085	MINOXIDIL	minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-1085	MINOXIDIL	minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-1085	MINOXIDIL	minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-1085	MINOXIDIL	minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-1086	MINOXIDIL	minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-1086	MINOXIDIL	minoxidil	Bryant Ranch Prepack	ANDA	Current
63629-1086	MINOXIDIL	minoxidil	Bryant Ranch Prepack	ANDA	Current
68151-2031	MINOXIDIL	minoxidil	Carilion Materials Management	ANDA	Current
70518-3419	MINOXIDIL	minoxidil	REMEDYREPACK INC.	ANDA	Current
72789-278	MINOXIDIL	minoxidil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-279	MINOXIDIL	minoxidil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current