Application 210892
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | SOLUTION;INTRAVENOUS | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | No | No |
| 002 | LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | SOLUTION;INTRAVENOUS | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210892-001 | LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | |
| A210892-002 | LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210892-001 | AP |
| A210892-002 | AP |
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 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2018-09-14 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210892-001 | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210892-002 | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2018-09-14 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210892-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210892-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210892-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210892-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210892-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210892-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210892-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210892-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210892-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210892-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210892-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210892-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210892-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210892-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210892-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210892-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210892-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210892-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210892-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210892-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210892-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210892-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210892-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210892-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210892-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210892-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210892-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210892-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210892-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210892-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210892-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210892-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210892-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210892-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210892-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A210892-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A210892-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210892-002 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210892-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A210892-002 | AP | 1 | 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 |
|---|---|---|---|---|---|---|
| levoleucovorin | LEVOLEUCOVORIN | Gland Pharma Limited | dbb3613c-78a9-4a96-a766-17e7a9e8809b | 2020-12-01 | Warnings, Adverse reactions | 210892 ANDA210892 68083-279 68083-278 |
| LEVOLEUCOVORIN | LEVOLEUCOVORIN | Dr.Reddy's Laboratories Inc | c003aaed-89c3-d6a6-0d34-18851b7e1255 | 2017-12-31 | Warnings, Adverse reactions | 210892 ANDA210892 43598-771 43598-773 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-890 | LEVOLEUCOVORIN | LEVOLEUCOVORIN | NorthStar RxLLC | ANDA | Current |
| 16714-890 | LEVOLEUCOVORIN | LEVOLEUCOVORIN | NorthStar RxLLC | ANDA | Current |
| 16714-890 | LEVOLEUCOVORIN | LEVOLEUCOVORIN | NorthStar RxLLC | ANDA | Current |
| 16714-890 | LEVOLEUCOVORIN | LEVOLEUCOVORIN | NorthStar RxLLC | ANDA | Current |
| 16714-915 | LEVOLEUCOVORIN | LEVOLEUCOVORIN | NorthStar RxLLC | ANDA | Current |
| 16714-915 | LEVOLEUCOVORIN | LEVOLEUCOVORIN | NorthStar RxLLC | ANDA | Current |
| 16714-915 | LEVOLEUCOVORIN | LEVOLEUCOVORIN | NorthStar RxLLC | ANDA | Current |
| 16714-915 | LEVOLEUCOVORIN | LEVOLEUCOVORIN | NorthStar RxLLC | ANDA | Current |
| 43598-771 | LEVOLEUCOVORIN | LEVOLEUCOVORIN | Dr.Reddy's Laboratories Inc | ANDA | Current |
| 43598-773 | LEVOLEUCOVORIN | LEVOLEUCOVORIN | Dr.Reddy's Laboratories Inc | ANDA | Current |
| 68083-278 | levoleucovorin | Levoleucovorin | Gland Pharma Limited | ANDA | Current |
| 68083-278 | levoleucovorin | Levoleucovorin | Gland Pharma Limited | ANDA | Current |
| 68083-278 | levoleucovorin | Levoleucovorin | Gland Pharma Limited | ANDA | Current |
| 68083-279 | levoleucovorin | Levoleucovorin | Gland Pharma Limited | ANDA | Current |
| 68083-279 | levoleucovorin | Levoleucovorin | Gland Pharma Limited | ANDA | Current |
| 68083-279 | levoleucovorin | Levoleucovorin | Gland Pharma Limited | ANDA | Current |
| 72266-120 | levoleucovorin | Levoleucovorin | Fosun Pharma USA Inc. | ANDA | Current |
| 72266-120 | Levoleucovorin | Levoleucovorin | Fosun Pharma USA Inc. | ANDA | Current |
| 72266-120 | Levoleucovorin | Levoleucovorin | Fosun Pharma USA Inc. | ANDA | Current |
| 72266-121 | levoleucovorin | Levoleucovorin | Fosun Pharma USA Inc. | ANDA | Current |
| 72266-121 | Levoleucovorin | Levoleucovorin | Fosun Pharma USA Inc. | ANDA | Current |
| 72266-121 | Levoleucovorin | Levoleucovorin | Fosun Pharma USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54452 | ORIG | 2018-06-05 |