Application 021175
- Type
- NDA
- Sponsor
- US ARMY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATNAA | ATROPINE; PRALIDOXIME CHLORIDE | INJECTABLE;INTRAMUSCULAR | 2.1MG/0.7ML;600MG/2ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021175-001 | ATNAA | ATROPINE; PRALIDOXIME CHLORIDE | 2.1MG/0.7ML;600MG/2ML | INJECTABLE / INTRAMUSCULAR | 2002-01-17 |
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 | N021175-001 | ATNAA | 2.1MG/0.7ML;600MG/2ML | INJECTABLE / INTRAMUSCULAR | 2002-01-17 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N021175-001 | ATNAA | 2.1MG/0.7ML;600MG/2ML | INJECTABLE / INTRAMUSCULAR | 2002-01-17 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021175-001 | ATNAA | 2.1MG/0.7ML;600MG/2ML | INJECTABLE / INTRAMUSCULAR | 2002-01-17 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021175-001 | ATNAA | 2.1MG/0.7ML;600MG/2ML | INJECTABLE / INTRAMUSCULAR | 2002-01-17 | 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 |
|---|---|---|---|---|---|---|
| ATNAA atropine and pralidoxime chloride Auto-Injector | ATROPINE AND PRALIDOXIME CHLORIDE | Meridian Medical Technologies, LLC | 596c7a8f-27cd-4de2-9491-476f43570b8b | 2022-07-18 | Warnings, Adverse reactions | 021175 NDA021175 11704-777 |
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 |
|---|---|---|---|---|---|
| 11704-777 | ATNAA atropine and pralidoxime chloride | atropine and pralidoxime chloride | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-777 | ATNAA atropine and pralidoxime chloride | atropine and pralidoxime chloride | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-777 | ATNAA atropine and pralidoxime chloride | atropine and pralidoxime chloride | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-777 | ATNAA atropine and pralidoxime chloride | atropine and pralidoxime chloride | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-777 | ATNAA atropine and pralidoxime chloride | atropine and pralidoxime chloride | Meridian Medical Technologies LLC | NDA | Current |
| 11704-777 | ATNAA atropine and pralidoxime chloride | atropine and pralidoxime chloride | Meridian Medical Technologies LLC | NDA | Current |
| 11704-777 | ATNAA atropine and pralidoxime chloride | atropine and pralidoxime chloride | Meridian Medical Technologies, LLC | NDA | Current |