Application 040796

Type: ANDA
Sponsor: LEADING PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOLIC ACID	FOLIC ACID	TABLET;ORAL	1MG	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
A040796-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA		2009-01-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040796-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040796-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-01-12	`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	A040796-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040796-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040796-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040796-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040796-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040796-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040796-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040796-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040796-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040796-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040796-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040796-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040796-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040796-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040796-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040796-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040796-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040796-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040796-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040796-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040796-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040796-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040796-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040796-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040796-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040796-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040796-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040796-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040796-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040796-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040796-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040796-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040796-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040796-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040796-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040796-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040796-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040796-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040796-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040796-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOLIC ACID	FOLIC ACID	Unit Dose Solutions, Inc.	54db8b21-87b9-5e0c-e063-6394a90ae8ea	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040796 application number: ANDA040796
Folic Acid	FOLIC ACID	NuCare Pharmaceuticals, Inc.	3f14442c-81ad-0bad-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040796 application number: ANDA040796 ndc (product): 66267-217
FOLIC ACID	FOLIC ACID	NuCare Pharmaceuticals,Inc.	7873790c-d722-cd9a-e053-2991aa0a23a3	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040796 application number: ANDA040796 ndc (product): 68071-4602
FOLIC ACID	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	141bb721-cd20-5bba-e063-6394a90ab8fa	2024-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040796 application number: ANDA040796
FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	0b263a1e-260b-4775-a76e-766add336f12	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040796 application number: ANDA040796 ndc (product): 71335-0766
FOLIC ACID	FOLIC ACID	Proficient Rx LP	607d23e8-21ef-4d73-88f1-990cf267d22e	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040796 application number: ANDA040796 ndc (product): 71205-913
FOLIC ACID	FOLIC ACID	Leading Pharma, LLC	1ba8c407-9613-4319-ac40-0a429cb0f3f4	2019-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040796 application number: ANDA040796 ndc (product): 69315-127

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-0200	Folic Acid	Folic Acid	A-S Medication Solutions	ANDA	Current
50090-2604	Folic Acid	FOLIC ACID	A-S Medication Solutions	ANDA	Current
50090-2604	Folic Acid	FOLIC ACID	A-S Medication Solutions	ANDA	Current
50090-2604	Folic Acid	FOLIC ACID	A-S Medication Solutions	ANDA	Current
55700-698	FOLIC ACID	FOLIC ACID	Quality Care Products, LLC	ANDA	Current
58118-0137	Folic Acid	FOLIC ACID	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0137	Folic Acid	FOLIC ACID	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0137	Folic Acid	FOLIC ACID	Clinical Solutions Wholesale, LLC	ANDA	Current
64125-127	Folic Acid	Folic Acid	Excellium Pharmaceutical Inc.	ANDA	Current
66267-217	Folic Acid	FOLIC ACID	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-217	Folic Acid	FOLIC ACID	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-217	Folic Acid	FOLIC ACID	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4602	FOLIC ACID	FOLIC ACID	NuCare Pharmaceuticals,In	ANDA	Current
68071-4602	FOLIC ACID	FOLIC ACID	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4602	FOLIC ACID	FOLIC ACID	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6950	Folic Acid	Folic Acid	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6950	Folic Acid	Folic Acid	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7877	FOLIC ACID	FOLIC ACID	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7877	FOLIC ACID	FOLIC ACID	Preferred Pharmaceuticals Inc.	ANDA	Current
69315-127	FOLIC ACID	FOLIC ACID	Leading Pharma, LLC	ANDA	Current
70518-3198	FOLIC ACID	FOLIC ACID	REMEDYREPACK INC.	ANDA	Current
70518-3198	FOLIC ACID	FOLIC ACID	REMEDYREPACK INC.	ANDA	Current
70518-3198	FOLIC ACID	FOLIC ACID	REMEDYREPACK INC.	ANDA	Current
70518-3198	FOLIC ACID	FOLIC ACID	REMEDYREPACK INC.	ANDA	Current
71205-913	FOLIC ACID	FOLIC ACID	Proficient Rx LP	ANDA	Current
71205-913	FOLIC ACID	FOLIC ACID	Proficient Rx LP	ANDA	Current
71335-0136	Folic Acid	Folic Acid	Bryant Ranch Prepack	ANDA	Current
71335-0766	FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	ANDA	Current
71335-0766	FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	ANDA	Current
76413-163	FOLIC ACID	FOLIC ACID	Central Texas Community Health Centers	ANDA	Current