Application 018342
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WELLCOVORIN | LEUCOVORIN CALCIUM | TABLET;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | WELLCOVORIN | LEUCOVORIN CALCIUM | TABLET;ORAL | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018342-001 | WELLCOVORIN | LEUCOVORIN CALCIUM | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | |
| N018342-002 | WELLCOVORIN | LEUCOVORIN CALCIUM | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1983-07-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018342-001 | WELLCOVORIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018342-002 | WELLCOVORIN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1983-07-08 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Leucovorin Calcium | LEUCOVORIN CALCIUM | American Health Packaging | f7004cbd-9827-466e-9683-adce4f13c6a6 | 2026-07-01 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Sagent Pharmaceuticals | c0cbcbf6-6fd2-4cf3-877a-bb0fe3df4e59 | 2026-06-16 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Teva Pharmaceuticals USA, Inc. | 94669fc8-3c1c-4228-be27-09a1cd468c36 | 2026-03-31 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Major Pharmaceuticals | 273407f5-0be2-435a-b7a8-f21be8ffbb3c | 2026-03-27 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | Leading Pharma, LLC | c8102043-79f2-421a-b849-94bac19007a6 | 2026-03-27 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Ingenus Pharmaceuticals, LLC | 7409cdee-9093-47af-a4c4-2c55ce1b6361 | 2026-03-18 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| VYKOURA | LEUCOVORIN CALCIUM | Avyxa Pharma, LLC | d122b875-435e-4e00-b945-7a0546df95c2 | 2026-03-12 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Sagent Pharmaceuticals | 9d0e5356-ff39-4a8e-944c-e808a21ef4b2 | 2026-03-11 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Hikma Pharmaceuticals USA Inc. | 33663425-4731-4977-9127-9e59b6b91497 | 2026-03-10 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | GLENMARK PHARMACEUTICALS INC., USA | 79d023ab-7d77-48c1-8f47-ea322fd58c2b | 2025-12-09 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Gland Pharma Limited | 968b192b-72f3-41b0-a1f5-bab8a96d3419 | 2025-11-13 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| leucovorin calcium | LEUCOVORIN CALCIUM | BluePoint Laboratories | f579879c-7d53-4663-8ad8-84b8b645cda5 | 2025-09-29 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| leucovorin calcium | LEUCOVORIN CALCIUM | Meitheal Pharmaceuticals Inc. | 9df20901-6980-4d4e-89ec-40f3c1f91852 | 2025-03-19 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Slate Run Pharmaceuticals, LLC | d8bdd60c-9a1c-4ef4-ba6b-b911849128f1 | 2024-12-27 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin calcium | LEUCOVORIN CALCIUM | Fresenius Kabi USA, LLC | 4b72d1fd-f389-45d9-b43b-510b45c92263 | 2024-10-14 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Fresenius Kabi USA, LLC | ab691d4e-e0d1-4ba1-9c7a-1cdcfcc3c17c | 2024-10-14 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin calcium | LEUCOVORIN CALCIUM | Fresenius Kabi USA, LLC | d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee | 2024-10-14 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Epic Pharma LLC | 2627a485-05b5-4dab-ac20-dc840e5c469d | 2023-11-08 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Hikma Pharmaceuticals USA Inc. | f198ab39-9394-4280-be44-93a88264a450 | 2022-06-23 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | Mylan Institutional LLC | 1cb701ca-2478-4268-9d69-80293965d59d | 2022-06-01 | Warnings, Adverse reactions | LEUCOVORIN CALCIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.