Application 020207
- Type
- NDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALKERAN | MELPHALAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/VIAL | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020207-001 | ALKERAN | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 |
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 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | RLD | 1992-11-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | RLD | 1992-11-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | AP | RLD | 1992-11-18 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | AP | RLD | 1992-11-18 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | AP | RLD | 1992-11-18 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | AP | RLD | 1992-11-18 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | AP | RLD | 1992-11-18 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | AP | RLD | 1992-11-18 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020207-001 | ALKERAN | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-11-18 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020207-001 | AP | 1 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N020207-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020207-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020207-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020207-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020207-001 | AP | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Melphalan hydrochloride | MELPHALAN HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 2c18beeb-7bd4-4591-94cb-9d7156c1b8e0 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan | MELPHALAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | e9c2efee-173d-4795-96d8-7aae5b3a3073 | 2026-01-14 | Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan Hydrochloride | MELPHALAN HYDROCHLORIDE | Arthur Group LLC | 2254450e-4803-b947-e063-6394a90a4624 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan hydrochloride | MELPHALAN HYDROCHLORIDE | BPI Labs LLC | dab93975-0587-4f12-848c-9130bb02d036 | 2025-12-05 | Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan Hydrochloride | MELPHALAN HYDROCHLORIDE | Qilu Pharmaceutical Co., Ltd. | 91948ff9-6070-485b-b4b7-3cb477c1b24c | 2024-07-04 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 24006cbf-4e91-4bb2-9627-25b4ebc9470a | 2024-06-21 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan Hydrochloride | MELPHALAN HYDROCHLORIDE | Sagent Pharmaceuticals | 35f3d9fe-3c2f-4362-9d40-cdab014cac38 | 2024-03-25 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan Hydrochloride | MELPHALAN HYDROCHLORIDE | Dr.Reddy's Laboratories Inc | bd5e4db5-8787-4428-2cb6-ef6f8a5e08af | 2024-02-27 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan Hydrochloride | MELPHALAN HYDROCHLORIDE | Avenacy Inc. | 8edd78a9-d762-4578-a610-28d6595f4bf3 | 2023-12-18 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan hydrochloride | MELPHALAN HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | d99b3865-e0f0-482a-9ec6-da642e5104ea | 2021-06-07 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan Hydrochloride | MELPHALAN HYDROCHLORIDE | Mylan Institutional LLC | a8bf1877-fd06-4ef6-b82d-fe0ff1956bde | 2020-09-16 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan hydrochloride | MELPHALAN HYDROCHLORIDE | Fosun Pharma USA Inc | 54712714-744d-4deb-83b2-694da49a9272 | 2019-07-28 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan hydrochloride | MELPHALAN HYDROCHLORIDE | Gland Pharma Limited | ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0 | 2019-06-07 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
| Melphalan Hydrochloride | MELPHALAN HYDROCHLORIDE | Dr.Reddy's Laboratories Inc | d4705154-3050-1a5c-950f-e24b51487401 | 2018-04-10 | Boxed warning, Warnings, Adverse reactions | MELPHALAN HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52609-3001 | ALKERAN | melphalan hydrochloride | ApoPharma USA, Inc. | NDA | Current |
| 52609-3001 | ALKERAN | melphalan hydrochloride | ApoPharma USA, Inc. | NDA | Current |