Application 211064

Type: ANDA
Sponsor: ATHEM

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
A211064-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA		2019-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211064-001	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	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`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	A211064-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211064-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211064-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211064-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211064-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211064-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211064-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211064-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211064-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211064-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211064-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211064-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211064-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211064-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211064-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211064-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211064-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211064-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211064-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211064-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211064-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211064-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211064-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211064-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211064-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211064-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211064-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211064-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211064-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211064-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211064-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211064-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211064-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211064-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211064-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211064-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211064-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211064-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211064-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211064-001	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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Folic Acid	FOLIC ACID	Rising Pharma Holdings, Inc.	0baa10dd-6d1d-4946-8236-566451132da3	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064 ndc (product): 16571-881
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	a1b71c5d-c842-43fd-9557-2bb4e934b914	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064 ndc (product): 63629-9257
Folic Acid	FOLIC ACID	Preferred Pharmaceuticals Inc.	b4c3a754-64cd-499a-a32f-a6e935c41355	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	40ab3c91-5a5b-fa1d-e063-6394a90a7454	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	4889d474-bd72-46ba-81d6-5511d8a85abb	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	41914ac8-f4f5-4d70-b9f2-9f88c59d67a6	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	1383dce2-0b81-4694-a662-27576f867eae	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Method Pharmaceuticals, LLC	b9c315ff-cecb-8b75-e053-2995a90aa204	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064 ndc (product): 58657-151
Folic Acid	FOLIC ACID	REMEDYREPACK INC.	bda4687e-929a-434d-ab59-909cf2ed73a2	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	NuCare Pharmaceuticals,Inc.	fa43f66c-9ae4-cd36-e053-6394a90a1526	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	fd0ec9f8-f547-4e5a-9847-a7ddfc3344bc	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064 ndc (product): 63629-9258
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	1b050122-73e9-48c7-9b26-431eaadddcfe	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	A-S Medication Solutions	16f8a1a1-ee81-4cd3-85e7-e1eae83fad67	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	A-S Medication Solutions	b48f4a4e-ece7-4bbb-b659-ed446cd9f0c9	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Proficient Rx LP	32203472-8724-4ba7-b0be-d834c3d7f074	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	f8ffce0d-2b94-4a14-a08e-97646436cf6d	2023-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-881	Folic Acid	Folic Acid	Rising Pharma Holdings, Inc.	ANDA	Current
58657-151	Folic Acid	Folic Acid	Method Pharmaceuticals, LLC	ANDA	Current
58657-151	Folic Acid	Folic Acid	Method Pharmaceuticals, LLC	ANDA	Current
58657-151	Folic Acid	Folic Acid	Method Pharmaceuticals, LLC	ANDA	Current
63629-9257	Folic Acid	Folic Acid	Bryant Ranch Prepack	ANDA	Current
63629-9258	Folic Acid	Folic Acid	Bryant Ranch Prepack	ANDA	Current
73152-141	Folic Acid	Folic Acid	Athem LLC	ANDA	Current