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| N005897-004 | FOLVITE | FOLIC ACID | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | ||
| N005897-008 | FOLVITE | FOLIC ACID | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N005897-008 | FOLVITE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N005897-004 | FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N005897-008 | FOLVITE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 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… |
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 | 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 |
| Folic Acid | FOLIC ACID | Bryant Ranch Prepack | 1383dce2-0b81-4694-a662-27576f867eae | 2025-10-22 | Warnings, Adverse reactions | FOLIC ACID |
| FOLIC ACID | FOLIC ACID | Bryant Ranch Prepack | 93580111-3e70-4a87-8834-c7aa99ec75e3 | 2025-10-21 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Method Pharmaceuticals, LLC | b9c315ff-cecb-8b75-e053-2995a90aa204 | 2025-10-21 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Bryant Ranch Prepack | 3d3d6927-6138-485a-ad72-abd7ca167af7 | 2025-10-20 | Warnings, Adverse reactions | 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 | FOLIC ACID |
| FOLIC ACID | FOLIC ACID | PD-Rx Pharmaceuticals, Inc. | 726bb436-69e3-452f-9f28-153b58bf3ca5 | 2025-03-13 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Preferred Pharmaceuticals Inc. | a4fd896d-0a44-4e53-bbb0-d716765e58b1 | 2025-02-13 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Coupler LLC | 2d98f4c3-9b7a-f122-e063-6294a90a6a00 | 2025-02-07 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | NuCare Pharmaceuticals,Inc. | fa43f66c-9ae4-cd36-e053-6394a90a1526 | 2025-02-04 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | NuCare Pharmaceuticals,Inc. | 065e403b-7ba8-b584-e063-6294a90a15ec | 2025-01-31 | Warnings, Adverse reactions | FOLIC ACID |
| FOLIC ACID | FOLIC ACID | Bryant Ranch Prepack | 0e7cb7ea-c94e-4ce6-8149-311dc9c94e03 | 2025-01-28 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Bryant Ranch Prepack | ceedca87-e390-4123-8de5-8c2a28bd0377 | 2025-01-21 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | DIRECT RX | bfcb0849-6d9b-7705-e053-2a95a90a6541 | 2025-01-17 | Warnings, Adverse reactions | FOLIC ACID |
| Ventrixyl | FOLIC ACID | PureTek Corporation | c29dc729-93be-2a20-e053-2a95a90a8ca3 | 2024-12-03 | Warnings, Adverse reactions | FOLIC ACID |
| FOLIC ACID | FOLIC ACID | SUNRISE PHARMACEUTICAL, INC. | 6854412b-7ecb-4107-85eb-730f14e23f06 | 2024-12-03 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Bryant Ranch Prepack | f4ede23e-f091-46cb-b120-772ee71b8cb3 | 2024-10-31 | Warnings, Adverse reactions | FOLIC ACID |
| Folic acid | FOLIC ACID | Chartwell RX, LLC. | 9a533666-8906-438e-adf7-11bb162ecb63 | 2024-10-28 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Amneal Pharmaceuticals LLC | c8fe09f0-b32b-43e3-8de7-ed38593b33b4 | 2024-10-25 | Warnings, Adverse reactions | FOLIC ACID |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.