Application 018035
- Type
- NDA
- Sponsor
- JUBILANT DRAXIMAGE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DRAXIMAGE MDP-10 | TECHNETIUM TC-99M MEDRONATE | INJECTABLE;INJECTION | N/A | No | No |
| 002 | DRAXIMAGE MDP-25 | TECHNETIUM TC-99M MEDRONATE | INJECTABLE;INJECTION | N/A | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018035-001 | DRAXIMAGE MDP-10 | TECHNETIUM TC-99M MEDRONATE | N/A | INJECTABLE / INJECTION | Approved before 1982 | ||
| N018035-002 | DRAXIMAGE MDP-25 | TECHNETIUM TC-99M MEDRONATE | N/A | INJECTABLE / INJECTION | RLD, RS | 2004-02-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N018035-001 | DRAXIMAGE MDP-10 | N/A | INJECTABLE / INJECTION | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N018035-002 | DRAXIMAGE MDP-25 | N/A | INJECTABLE / INJECTION | RLD, RS | 2004-02-27 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N018035-001 | DRAXIMAGE MDP-10 | N/A | INJECTABLE / INJECTION | Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N018035-002 | DRAXIMAGE MDP-25 | N/A | INJECTABLE / INJECTION | RLD, RS | 2004-02-27 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018035-001 | DRAXIMAGE MDP-10 | N/A | INJECTABLE / INJECTION | Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018035-002 | DRAXIMAGE MDP-25 | N/A | INJECTABLE / INJECTION | RLD, RS | 2004-02-27 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018035-001 | DRAXIMAGE MDP-10 | N/A | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018035-002 | DRAXIMAGE MDP-25 | N/A | INJECTABLE / INJECTION | RLD, RS | 2004-02-27 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Technetium Tc 99m Medronate | TECHNETIUM TC 99M MEDRONATE | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 3c91d0d8-6cc5-834c-bda0-aa83a873b9fb | 2025-03-05 | Warnings, Adverse reactions | 018035 NDA018035 65174-660 |
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 |
|---|---|---|---|---|---|
| 65174-660 | Technetium Tc 99m Medronate | Technetium Tc 99m Medronate | Jubilant DraxImage Inc., dba Jubilant Radiopharma | NDA | Current |
| 65174-660 | Technetium Tc 99m Medronate | Technetium Tc 99m Medronate | Jubilant DraxImage Inc | NDA | Current |