Application 040625

Type: ANDA
Sponsor: AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOLIC ACID	FOLIC ACID	TABLET;ORAL	1MG	No	Yes

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
A040625-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040625-001	AA

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`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	A040625-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040625-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040625-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040625-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040625-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040625-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040625-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040625-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040625-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040625-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040625-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040625-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040625-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040625-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040625-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040625-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040625-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040625-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040625-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040625-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040625-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040625-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040625-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040625-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040625-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040625-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040625-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040625-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040625-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040625-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040625-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040625-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040625-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040625-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040625-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040625-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040625-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040625-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040625-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040625-001	AA	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
Folic Acid	FOLIC ACID	Northwind Health Company, LLC	03b0aee4-804a-de63-e063-6394a90a6635	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	Major Pharmaceuticals	7778ac96-7817-455a-a177-22ecb276c67f	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625 ndc (product): 0904-7224
Folic Acid	FOLIC ACID	Cardinal Health 107, LLC	624469a1-ded9-453a-973e-c5a2f0602bb0	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	Cardinal Health 107, LLC	6dd867fe-597e-4915-8baf-98a605bf9324	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	Amneal Pharmaceuticals of New York LLC	fd85395e-6a0b-4072-a80b-36095c0c6dd6	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625 ndc (product): 53746-361
Folic Acid	FOLIC ACID	American Health Packaging	fc6dc1e1-f63e-4239-a1eb-67525569f68c	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625 ndc (product): 60687-681
Folic Acid	FOLIC ACID	NuCare Pharmaceuticals,Inc.	065e403b-7ba8-b584-e063-6294a90a15ec	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	Amneal Pharmaceuticals LLC	c8fe09f0-b32b-43e3-8de7-ed38593b33b4	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625 ndc (product): 65162-361
Folic Acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	d6c7ac9b-f44a-4f10-9d1d-efbebd37c313	2019-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625 ndc (product): 71610-235

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7814	Folic Acid	Folic Acid	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7814	Folic Acid	Folic Acid	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8427	Folic Acid	Folic Acid	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0904-7224	Folic Acid	Folic Acid	Major Pharmaceuticals	ANDA	Current
50090-4152	Folic Acid	Folic Acid	A-S Medication Solutions	ANDA	Current
50090-6112	Folic Acid	Folic Acid	A-S Medication Solutions	ANDA	Current
50268-345	Folic Acid	Folic Acid	AvPAK	ANDA	Current
50268-345	Folic Acid	Folic Acid	AvPAK	ANDA	Current
50268-345	Folic Acid	Folic Acid	AvPAK	ANDA	Current
50268-345	Folic Acid	Folic Acid	AvPAK	ANDA	Current
50436-3845	Folic Acid	Folic Acid	Unit Dose Services	ANDA	Current
53746-361	Folic Acid	Folic Acid	Amneal Pharmaceuticals of New York LLC	ANDA	Current
55154-2064	Folic Acid	Folic Acid	Cardinal Health	ANDA	Current
55154-2064	Folic Acid	Folic Acid	Cardinal Health	ANDA	Current
55154-2064	Folic Acid	Folic Acid	Cardinal Health	ANDA	Current
55154-2064	Folic Acid	Folic Acid	Cardinal Health 107, LLC	ANDA	Current
55154-2064	Folic Acid	Folic Acid	Cardinal Health	ANDA	Current
55289-492	Folic Acid	Folic Acid	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-492	Folic Acid	Folic Acid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-492	Folic Acid	Folic Acid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-492	Folic Acid	Folic Acid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-492	Folic Acid	Folic Acid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-492	Folic Acid	Folic Acid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60687-681	Folic Acid	Folic Acid	American Health Packaging	ANDA	Current
62584-897	Folic Acid	Folic Acid	American Health Packaging	ANDA	Current
62584-897	Folic Acid	Folic Acid	American Health Packaging	ANDA	Current
62584-897	Folic Acid	Folic Acid	American Health Packaging	ANDA	Current
63629-2816	Folic Acid	Folic Acid	Bryant Ranch Prepack	ANDA	Current
64725-0361	Folic Acid	Folic Acid	TYA Pharmaceuticals	ANDA	Current
65162-361	Folic Acid	Folic Acid	Amneal Pharmaceuticals LLC	ANDA	Current
65162-361	Folic Acid	Folic Acid	Amneal Pharmaceuticals LLC	ANDA	Current
65162-361	Folic Acid	Folic Acid	Amneal Pharmaceuticals LLC	ANDA	Current
65162-361	Folic Acid	Folic Acid	Amneal Pharmaceuticals LLC	ANDA	Current
68788-9479	Folic Acid	Folic Acid	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-3105	Folic Acid	Folic Acid	REMEDYREPACK INC.	ANDA	Current
70518-3567	Folic Acid	Folic Acid	REMEDYREPACK INC.	ANDA	Current
71610-235	Folic Acid	Folic Acid	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current