Application 018152
- Type
- NDA
- Sponsor
- JDS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESKALITH CR | LITHIUM CARBONATE | TABLET, EXTENDED RELEASE;ORAL | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018152-001 | ESKALITH CR | LITHIUM CARBONATE | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 |
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| 2026-08 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018152-001 | ESKALITH CR | 450MG | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018152-001 | ESKALITH CR | 450MG | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N018152-001 | ESKALITH CR | 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1982-03-29 | 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 |
|---|---|---|---|---|---|---|
| Lithium Carbonate | LITHIUM CARBONATE | A-S Medication Solutions | baf59ee7-1c98-4f77-96c5-7b50b7acb8f4 | 2023-11-17 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| Lithium carbonicum | LITHIUM CARBONATE | Boiron | 861df6e6-46cb-632d-e053-2a91aa0ae9a3 | 2023-11-13 | LITHIUM CARBONATE | |
| Lithium carbonicum | LITHIUM CARBONATE | Boiron | 68f8e2a1-0fe9-70e4-e053-2a91aa0a981d | 2023-11-13 | LITHIUM CARBONATE | |
| Lithium Carbonate | LITHIUM CARBONATE | Sun Pharmaceutical Industries, Inc. | d3284649-ed4c-4096-987b-4ac16b8278f2 | 2023-10-02 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| Lithium Carbonate | LITHIUM CARBONATE | NCS HealthCare of KY, LLC dba Vangard Labs | 204d94de-83e4-400e-bd6b-70b49813802c | 2023-08-22 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| Lithium Carbonate | LITHIUM CARBONATE | Hikma Pharmaceuticals USA Inc. | c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e | 2023-07-28 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| Lithium Carbonate | LITHIUM CARBONATE | Hikma Pharmaceuticals USA Inc. | a226a88d-eb57-4c96-afda-939801bca0a9 | 2023-06-28 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| lithium carbonate | LITHIUM CARBONATE | Bryant Ranch Prepack | bfececc8-b2ab-47d1-b126-1c6592bc9c26 | 2023-03-28 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| Lithium Carbonate | LITHIUM CARBONATE | Alembic Pharmaceuticals Limited | 8e950a50-689d-4bf8-87ce-cffd43c6d5c2 | 2023-01-30 | Boxed warning, Adverse reactions | LITHIUM CARBONATE |
| Lithium Carbonate | LITHIUM CARBONATE | Alembic Pharmaceuticals Limited | d1800f34-3d67-4b2f-874e-8639b125d853 | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| lithium carbonate | LITHIUM CARBONATE | Camber Pharmaceuticals, Inc. | 04518b80-7563-4544-bf05-04f286223faa | 2022-12-26 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| Lithium Carbonate | LITHIUM CARBONATE | Hikma Pharmaceuticals USA Inc. | 7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e | 2022-11-22 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| LITHIUM CARBONATE LITHIUM CARBONATE | LITHIUM CARBONATE | Alembic Pharmaceuticals Inc. | 4ca2b977-b94c-4232-9b7e-835db97c9544 | 2022-11-03 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| lithium carbonate | LITHIUM CARBONATE | Aphena Pharma Solutions - Tennessee, LLC | 2b81eabc-5c5a-4b63-88d4-3f13b45a683e | 2021-06-24 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
| Lithium Carbonate | LITHIUM CARBONATE | Proficient Rx LP | d3291474-8ef2-4cd8-aecc-2f550fd6a299 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | LITHIUM CARBONATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.