Application 005897
- Type
- NDA
- Sponsor
- WYETH PHARMS INC
Application Products#
| 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 |
Orange Book products#
| 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| N005897-004 | FOLVITE | FOLIC ACID | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | ||
| N005897-008 | FOLVITE | FOLIC ACID | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N005897-008 | FOLVITE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N005897-008 | FOLVITE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | 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 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | 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 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | 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 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | 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 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | 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 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | 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 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N005897-004 | FOLVITE | 1MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N005897-008 | FOLVITE | 5MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N005897-004 | FOLVITE | 1MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N005897-008 | FOLVITE | 5MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 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… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Folic Acid | FOLIC ACID | Rising Pharma Holdings, Inc. | 0baa10dd-6d1d-4946-8236-566451132da3 | 2026-07-24 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Northwind Health Company, LLC | 03b0aee4-804a-de63-e063-6394a90a6635 | 2026-07-13 | Warnings, Adverse reactions | FOLIC ACID |
| FOLIC ACID | FOLIC ACID | Unit Dose Solutions, Inc. | 54db8b21-87b9-5e0c-e063-6394a90ae8ea | 2026-06-22 | Warnings, Adverse reactions | FOLIC ACID |
| Vitramyn | FOLIC ACID | PureTek Corporation | c8af7616-5178-6df0-e053-2a95a90a334d | 2026-06-18 | Warnings, Adverse reactions | FOLIC ACID |
| FOLIC ACID | FOLIC ACID | Coupler LLC | 544e394d-3555-8ab1-e063-6394a90ade00 | 2026-06-15 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Major Pharmaceuticals | 7778ac96-7817-455a-a177-22ecb276c67f | 2026-05-26 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | QUAGEN PHARMACEUTICALS LLC | 354366ea-3702-4706-9fc0-0244b7278bd8 | 2026-05-20 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Cardinal Health 107, LLC | 624469a1-ded9-453a-973e-c5a2f0602bb0 | 2026-05-15 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Cardinal Health 107, LLC | 6dd867fe-597e-4915-8baf-98a605bf9324 | 2026-05-06 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Bryant Ranch Prepack | a1b71c5d-c842-43fd-9557-2bb4e934b914 | 2026-04-23 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Preferred Pharmaceuticals Inc. | b4c3a754-64cd-499a-a32f-a6e935c41355 | 2026-04-22 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Amneal Pharmaceuticals of New York LLC | fd85395e-6a0b-4072-a80b-36095c0c6dd6 | 2026-04-15 | Warnings, Adverse reactions | FOLIC ACID |
| Multitam | FOLIC ACID | PureTek Corporation | cee15842-4a9e-c6ba-e053-2a95a90aebc5 | 2026-04-13 | Warnings, Adverse reactions | FOLIC ACID |
| FOLIC ACID | FOLIC ACID | Ayurax, LLC | 96618bf8-6c03-4df3-9896-b7ef27ca392a | 2026-02-11 | Warnings, Adverse reactions | FOLIC ACID |
| QUIOFIC | FOLIC ACID | Solubiomix, LLC | b868b314-591d-458b-be82-2bcd0b73cce1 | 2026-02-08 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | XGen Pharmaceuticals DJB, Inc. | c5b2b84d-9f5e-4b81-ba10-9f2854e5dce9 | 2026-01-21 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Aphena Pharma Solutions - Tennessee, LLC | 40ab3c91-5a5b-fa1d-e063-6394a90a7454 | 2025-12-10 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | American Health Packaging | fc6dc1e1-f63e-4239-a1eb-67525569f68c | 2025-11-13 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Bryant Ranch Prepack | 4889d474-bd72-46ba-81d6-5511d8a85abb | 2025-11-04 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Bryant Ranch Prepack | 41914ac8-f4f5-4d70-b9f2-9f88c59d67a6 | 2025-10-29 | Warnings, Adverse reactions | FOLIC ACID |