Application 005897

Type: NDA
Sponsor: WYETH PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	FOLVITE	FOLIC ACID	TABLET;ORAL	1MG	No	No
008	FOLVITE	FOLIC ACID	INJECTABLE;INJECTION	5MG/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N005897-004	FOLVITE	FOLIC ACID	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982
N005897-008	FOLVITE	FOLIC ACID	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N005897-004	FOLVITE	1MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005897-008	FOLVITE	5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N005897-004	FOLVITE	1MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N005897-008	FOLVITE	5MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N005897-004	FOLVITE	1MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005897-008	FOLVITE	5MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005897-004	FOLVITE	1MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005897-008	FOLVITE	5MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N005897-004	FOLVITE	1MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N005897-008	FOLVITE	5MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N005897-004	FOLVITE	1MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N005897-008	FOLVITE	5MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N005897-004	FOLVITE	1MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N005897-008	FOLVITE	5MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N005897-004	FOLVITE	1MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N005897-008	FOLVITE	5MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N005897-004	FOLVITE	1MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N005897-008	FOLVITE	5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N005897-004	FOLVITE	1MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N005897-008	FOLVITE	5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N005897-004	FOLVITE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N005897-008	FOLVITE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N005897-004	FOLVITE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N005897-008	FOLVITE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N005897-004	FOLVITE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N005897-008	FOLVITE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N005897-004	FOLVITE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N005897-008	FOLVITE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N005897-004	FOLVITE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N005897-008	FOLVITE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N005897-004	FOLVITE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N005897-008	FOLVITE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N005897-004	FOLVITE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N005897-008	FOLVITE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N005897-004	FOLVITE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N005897-008	FOLVITE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N005897-004	FOLVITE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N005897-008	FOLVITE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N005897-004	FOLVITE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N005897-008	FOLVITE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3a93d1ddd44b…`

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 4 · 61 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Folic Acid	FOLIC ACID	REMEDYREPACK INC.	bda4687e-929a-434d-ab59-909cf2ed73a2	2026-09-11	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	REMEDYREPACK INC.	368b69a8-a021-47e3-a6d7-e3497d7363b1	2026-09-04	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Rising Pharma Holdings, Inc.	0baa10dd-6d1d-4946-8236-566451132da3	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Northwind Health Company, LLC	03b0aee4-804a-de63-e063-6394a90a6635	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	Unit Dose Solutions, Inc.	54db8b21-87b9-5e0c-e063-6394a90ae8ea	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Vitramyn	FOLIC ACID	PureTek Corporation	c8af7616-5178-6df0-e053-2a95a90a334d	2026-06-18	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
FOLIC ACID	FOLIC ACID	Coupler LLC	544e394d-3555-8ab1-e063-6394a90ade00	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Major Pharmaceuticals	7778ac96-7817-455a-a177-22ecb276c67f	2026-05-26	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	QUAGEN PHARMACEUTICALS LLC	354366ea-3702-4706-9fc0-0244b7278bd8	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Cardinal Health 107, LLC	624469a1-ded9-453a-973e-c5a2f0602bb0	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Cardinal Health 107, LLC	6dd867fe-597e-4915-8baf-98a605bf9324	2026-05-06	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	a1b71c5d-c842-43fd-9557-2bb4e934b914	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Preferred Pharmaceuticals Inc.	b4c3a754-64cd-499a-a32f-a6e935c41355	2026-04-22	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Amneal Pharmaceuticals of New York LLC	fd85395e-6a0b-4072-a80b-36095c0c6dd6	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Multitam	FOLIC ACID	PureTek Corporation	cee15842-4a9e-c6ba-e053-2a95a90aebc5	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	XGen Pharmaceuticals DJB, Inc.	c5b2b84d-9f5e-4b81-ba10-9f2854e5dce9	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	40ab3c91-5a5b-fa1d-e063-6394a90a7454	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	American Health Packaging	fc6dc1e1-f63e-4239-a1eb-67525569f68c	2025-11-13	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	4889d474-bd72-46ba-81d6-5511d8a85abb	2025-11-04	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	41914ac8-f4f5-4d70-b9f2-9f88c59d67a6	2025-10-29	Warnings, Adverse reactions	Name fallback generic name: FOLIC ACID

Reported adverse events (FAERS/openFDA)#

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