Application 040514

Type: ANDA
Sponsor: JUBILANT CADISTA

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 43.

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
A040514-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL			2005-06-14

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040514-001	FOLIC ACID	1MG	TABLET / ORAL	2005-06-14	`f41ea6bd6efb…`

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 3 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	fd0ec9f8-f547-4e5a-9847-a7ddfc3344bc	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Fresenius Kabi USA, LLC	e215318c-4f8b-4711-ae76-f370d1da0f3b	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	1b050122-73e9-48c7-9b26-431eaadddcfe	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	NuCare Pharmaceuticals, Inc.	3f14442c-81ad-0bad-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	A-S Medication Solutions	16f8a1a1-ee81-4cd3-85e7-e1eae83fad67	2024-07-22	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	A-S Medication Solutions	b48f4a4e-ece7-4bbb-b659-ed446cd9f0c9	2024-07-22	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	NuCare Pharmaceuticals,Inc.	7873790c-d722-cd9a-e053-2991aa0a23a3	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Proficient Rx LP	32203472-8724-4ba7-b0be-d834c3d7f074	2024-06-01	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	141bb721-cd20-5bba-e063-6394a90ab8fa	2024-03-20	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Modavar Pharmaceuticals LLC	0eea15e4-7e5d-44e9-818b-a0bdf5271c78	2023-12-25	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Cadila Pharmaceuticals Limited	103c2cdd-5822-48ba-b62a-e2b11aa444ef	2023-12-23	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	0b263a1e-260b-4775-a76e-766add336f12	2023-12-04	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	A-S Medication Solutions	21f7ccf1-1de6-4a6e-b017-2b85c9d62d13	2023-10-19	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	f8ffce0d-2b94-4a14-a08e-97646436cf6d	2023-06-15	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	A-S Medication Solutions	a9583b76-822d-486a-947a-2be6356637d0	2023-05-09	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID
Vitrexyl	FOLIC ACID	PureTek Corporation	ae064a9e-daba-fa86-e053-2a95a90a16a7	2023-01-11	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Vitrexate	FOLIC ACID	PureTek Corporation	b34fee43-bea9-45b7-e053-2a95a90aad4d	2023-01-11	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Venexa	FOLIC ACID	PureTek Corporation	ba130779-cdfd-086d-e053-2a95a90a2590	2023-01-11	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	dc4d097d-6e7e-4229-9853-04c31444d703	2022-08-12	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	Proficient Rx LP	607d23e8-21ef-4d73-88f1-990cf267d22e	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.