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 2 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	4889d474-bd72-46ba-81d6-5511d8a85abb	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	41914ac8-f4f5-4d70-b9f2-9f88c59d67a6	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	1383dce2-0b81-4694-a662-27576f867eae	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	93580111-3e70-4a87-8834-c7aa99ec75e3	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Method Pharmaceuticals, LLC	b9c315ff-cecb-8b75-e053-2995a90aa204	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	3d3d6927-6138-485a-ad72-abd7ca167af7	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	NCS HealthCare of KY, LLC dba Vangard Labs	76f51124-1e0f-499b-a6d1-7b4dbf313ca0	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	PD-Rx Pharmaceuticals, Inc.	726bb436-69e3-452f-9f28-153b58bf3ca5	2025-03-13	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Preferred Pharmaceuticals Inc.	a4fd896d-0a44-4e53-bbb0-d716765e58b1	2025-02-13	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Coupler LLC	2d98f4c3-9b7a-f122-e063-6294a90a6a00	2025-02-07	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	NuCare Pharmaceuticals,Inc.	fa43f66c-9ae4-cd36-e053-6394a90a1526	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	NuCare Pharmaceuticals,Inc.	065e403b-7ba8-b584-e063-6294a90a15ec	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	0e7cb7ea-c94e-4ce6-8149-311dc9c94e03	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	ceedca87-e390-4123-8de5-8c2a28bd0377	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	DIRECT RX	bfcb0849-6d9b-7705-e053-2a95a90a6541	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Ventrixyl	FOLIC ACID	PureTek Corporation	c29dc729-93be-2a20-e053-2a95a90a8ca3	2024-12-03	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	SUNRISE PHARMACEUTICAL, INC.	6854412b-7ecb-4107-85eb-730f14e23f06	2024-12-03	Warnings, Adverse reactions	Name fallback brand name: FOLIC ACID generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	f4ede23e-f091-46cb-b120-772ee71b8cb3	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: Folic Acid generic name: FOLIC ACID
Folic acid	FOLIC ACID	Chartwell RX, LLC.	9a533666-8906-438e-adf7-11bb162ecb63	2024-10-28	Warnings, Adverse reactions	Name fallback brand name: Folic acid generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Amneal Pharmaceuticals LLC	c8fe09f0-b32b-43e3-8de7-ed38593b33b4	2024-10-25	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.