Application 204418

Type: ANDA
Sponsor: NUVO PHARMS INC

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 1.

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
A204418-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA		2015-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204418-001	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 · 41 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	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A204418-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204418-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204418-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204418-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204418-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204418-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204418-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204418-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204418-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204418-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204418-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204418-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204418-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204418-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204418-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204418-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204418-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204418-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204418-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204418-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204418-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204418-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204418-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204418-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204418-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204418-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204418-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204418-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204418-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204418-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204418-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204418-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204418-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204418-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204418-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204418-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204418-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204418-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204418-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204418-001	AA	1	`cb3db0bc1861…`

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	Coupler LLC	544e394d-3555-8ab1-e063-6394a90ade00	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	93580111-3e70-4a87-8834-c7aa99ec75e3	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	PD-Rx Pharmaceuticals, Inc.	726bb436-69e3-452f-9f28-153b58bf3ca5	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418 ndc (product): 43063-791
FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	0e7cb7ea-c94e-4ce6-8149-311dc9c94e03	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418 ndc (product): 71335-0613
Folic Acid	FOLIC ACID	DIRECT RX	bfcb0849-6d9b-7705-e053-2a95a90a6541	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418 ndc (product): 72189-199
FOLIC ACID	FOLIC ACID	SUNRISE PHARMACEUTICAL, INC.	6854412b-7ecb-4107-85eb-730f14e23f06	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418 ndc (product): 11534-165
FOLIC ACID	FOLIC ACID	A-S Medication Solutions	21f7ccf1-1de6-4a6e-b017-2b85c9d62d13	2023-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	A-S Medication Solutions	a9583b76-822d-486a-947a-2be6356637d0	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418 ndc (product): 50090-3119
FOLIC ACID	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	dc4d097d-6e7e-4229-9853-04c31444d703	2022-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418 ndc (product): 71610-656

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-182	Folic Acid	Folic Acid	Marlex Pharmaceuticals Inc	ANDA	Current
10135-182	Folic Acid	Folic Acid	Marlex Pharmaceuticals Inc	ANDA	Current
10135-182	Folic Acid	Folic Acid	Marlex Pharmaceuticals Inc	ANDA	Current
11534-165	FOLIC ACID	folic acid	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-165	FOLIC ACID	folic acid	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-165	FOLIC ACID	folic acid	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
43063-791	FOLIC ACID	folic acid	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-791	FOLIC ACID	folic acid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-791	FOLIC ACID	folic acid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-791	FOLIC ACID	folic acid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-791	FOLIC ACID	folic acid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-791	FOLIC ACID	folic acid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-3119	FOLIC ACID	folic acid	A-S Medication Solutions	ANDA	Current
50090-3119	FOLIC ACID	folic acid	A-S Medication Solutions	ANDA	Current
50090-3119	FOLIC ACID	folic acid	A-S Medication Solutions	ANDA	Current
50090-3119	FOLIC ACID	folic acid	A-S Medication Solutions	ANDA	Current
53217-355	FOLIC ACID	folic acid	Aidarex Pharmaceuticals LLC	ANDA	Current
67544-989	Folic Acid	Folic Acid	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68071-1800	FOLIC ACID	folic acid	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4175	FOLIC ACID	folic acid	NuCare Pharmaceuticals,In	ANDA	Current
68071-4175	FOLIC ACID	folic acid	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4175	FOLIC ACID	folic acid	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7053	FOLIC ACID	folic acid	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7053	FOLIC ACID	folic acid	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7053	FOLIC ACID	folic acid	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7053	FOLIC ACID	folic acid	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7053	FOLIC ACID	folic acid	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0609	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0609	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0609	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0609	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0609	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0609	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0866	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0866	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0866	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0866	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0866	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0866	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0866	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0866	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70518-0866	FOLIC ACID	folic acid	REMEDYREPACK INC.	ANDA	Current
70934-968	FOLIC ACID	folic acid	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0613	FOLIC ACID	folic acid	Bryant Ranch Prepack	ANDA	Current
71335-0613	FOLIC ACID	folic acid	Bryant Ranch Prepack	ANDA	Current
71335-0613	FOLIC ACID	folic acid	Bryant Ranch Prepack	ANDA	Current
71610-656	FOLIC ACID	folic acid	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-199	Folic Acid	Folic Acid	DIRECT RX	ANDA	Current