Application 017744
- Type
- NDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MOTOFEN HALF-STRENGTH | ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE | TABLET;ORAL | 0.025MG;0.5MG | No | No |
| 002 | MOTOFEN | ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE | TABLET;ORAL | 0.025MG;1MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017744-001 | MOTOFEN HALF-STRENGTH | ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE | 0.025MG;0.5MG | TABLET / ORAL | Approved before 1982 | ||
| N017744-002 | MOTOFEN | ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE | 0.025MG;1MG | TABLET / ORAL | RLD, RS, Approved before 1982 |
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 | N017744-001 | MOTOFEN HALF-STRENGTH | 0.025MG;0.5MG | TABLET / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N017744-002 | MOTOFEN | 0.025MG;1MG | TABLET / ORAL | RLD, RS, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N017744-001 | MOTOFEN HALF-STRENGTH | 0.025MG;0.5MG | TABLET / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N017744-002 | MOTOFEN | 0.025MG;1MG | TABLET / ORAL | RLD, RS, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N017744-001 | MOTOFEN HALF-STRENGTH | 0.025MG;0.5MG | TABLET / ORAL | Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N017744-002 | MOTOFEN | 0.025MG;1MG | TABLET / ORAL | RLD, RS, Approved before 1982 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N017744-001 | MOTOFEN HALF-STRENGTH | 0.025MG;0.5MG | TABLET / ORAL | Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N017744-002 | MOTOFEN | 0.025MG;1MG | TABLET / ORAL | RLD, RS, Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| Motofen | DIFENOXIN AND ATROPINE SULFATE | Legacy Pharma USA Inc. | 1fa11c67-5492-469c-9475-6bfa0e5e9ff8 | 2026-03-23 | Warnings, Adverse reactions | 017744 NDA017744 |
| Motofen | DIFENOXIN AND ATROPINE SULFATE | Sebela Pharmaceuticals Inc. | 4cd3f029-a5e3-5812-e054-00144ff8d46c | 2025-11-08 | Warnings, Adverse reactions | 017744 NDA017744 54766-200 |
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 |
|---|---|---|---|---|---|
| 54766-200 | Motofen | difenoxin and atropine sulfate | Sebela Pharmaceuticals Inc. | NDA | Current |