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| EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | |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HYDROCHLORIDE | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | |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HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 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 | 74a2ff9319b5… | |
| 2019-12-13 00:20 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 | 74a2ff9319b5… | |
| 2019-12-13 00:20 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 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | 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 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | 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 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | 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 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | 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 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | 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 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | 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 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N200199-003 | TOPOTECAN | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | 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 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | 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 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | 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 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N200199-001 | TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N200199-002 | TOPOTECAN | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INTRAVENOUS | RLD | 2011-02-25 | c0c555d07b60… |
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 |