Application 200199
- Type
- NDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOPOTECAN | TOPOTECAN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | TOPOTECAN | TOPOTECAN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | TOPOTECAN | TOPOTECAN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N200199-001 | TOPOTECAN | TOPOTECAN HYDROCHLORIDE | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | |
| N200199-002 | TOPOTECAN | TOPOTECAN HYDROCHLORIDE | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | |
| N200199-003 | TOPOTECAN | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | b6019088-cd94-43b4-b5ce-ba20b6b8021e | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | TOPOTECAN HYDROCHLORIDE |
| Topotecan | TOPOTECAN | Accord Healthcare Inc. | 7636bc1e-77b6-46ad-9df0-c8bb1c5e503f | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | Topotecan |
| topotecan hydrochloride | TOPOTECAN HYDROCHLORIDE | Accord Healthcare, Inc. | 729b2b22-1344-44f3-b614-14f6ec3c263e | 2024-10-04 | Boxed warning, Warnings, Adverse reactions | TOPOTECAN HYDROCHLORIDE |
| Topotecan hydrochloride | TOPOTECAN HYDROCHLORIDE | Actavis Pharma, Inc. | 996430c0-ee26-4ed9-82b8-a8b645becba6 | 2022-08-31 | Boxed warning, Warnings, Adverse reactions | TOPOTECAN HYDROCHLORIDE |
| HYCAMTIN | TOPOTECAN HYDROCHLORIDE | Novartis Pharmaceuticals Corporation | eeee060c-a9ec-423e-a374-8484009f8524 | 2022-07-07 | Boxed warning, Warnings, Adverse reactions | TOPOTECAN HYDROCHLORIDE |
| Topotecan | TOPOTECAN | Hospira, Inc. | 1d4e1cce-c57e-4a8b-be96-f95a2778e221 | 2021-02-01 | Boxed warning, Warnings, Adverse reactions | Topotecan |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66758-051 | Topotecan | Topotecan | Sandoz Inc | NDA | Current |