Application 090035

Type: ANDA
Sponsor: CHARTWELL MOLECULAR

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
A090035-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA		2009-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090035-001	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	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090035-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2009-06-09	`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	A090035-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090035-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090035-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090035-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090035-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090035-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090035-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090035-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090035-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090035-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090035-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090035-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090035-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090035-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090035-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090035-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090035-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090035-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090035-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090035-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090035-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090035-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090035-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090035-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090035-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090035-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090035-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090035-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090035-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090035-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090035-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090035-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090035-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090035-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090035-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090035-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090035-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090035-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090035-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090035-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Folic acid	FOLIC ACID	Chartwell RX, LLC.	9a533666-8906-438e-adf7-11bb162ecb63	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090035 application number: ANDA090035 ndc (product): 62135-210
Folic acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	454f9fdc-fd8c-4838-8e5b-10f4c74110dd	2021-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090035 application number: ANDA090035 ndc (product): 71610-545

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9717	Folic Acid	Folic Acid	West-ward Pharmaceutical Corp	ANDA	Current
33261-811	Folic Acid	Folic Acid	Aidarex Pharmaceuticals LLC	ANDA	Current
43353-824	FOLIC ACID	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
62135-210	Folic acid	Folic Acid	Chartwell RX LLC	ANDA	Current
62135-210	Folic acid	Folic Acid	Chartwell RX LLC	ANDA	Current
62135-210	Folic acid	Folic Acid	Chartwell RX, LLC.	ANDA	Current
62135-210	Folic acid	Folic Acid	Chartwell RX, LLC.	ANDA	Current
68071-2204	Folic acid	Folic Acid	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2204	Folic acid	Folic Acid	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7624	Folic acid	Folic Acid	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7624	Folic acid	Folic Acid	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9795	Folic Acid	Folic Acid	Preferred Pharmaceuticals, Inc.	ANDA	Current
70934-597	Folic acid	Folic Acid	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71610-545	Folic acid	Folic Acid	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76282-210	FOLIC ACID	FOLIC ACID	Exelan Pharmaceuticals, Inc.	ANDA	Current