Application 050703
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BACTROBAN | MUPIROCIN CALCIUM | OINTMENT;NASAL | EQ 2% BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050703-001 | BACTROBAN | MUPIROCIN CALCIUM | EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / NASAL | RLD | 1995-09-18 |
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 | N050703-001 | BACTROBAN | EQ 2% BASE | OINTMENT / NASAL | RLD | 1995-09-18 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N050703-001 | BACTROBAN | EQ 2% BASE | OINTMENT / NASAL | RLD | 1995-09-18 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050703-001 | BACTROBAN | EQ 2% BASE | OINTMENT / NASAL | RLD | 1995-09-18 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N050703-001 | BACTROBAN | EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / NASAL | RLD | 1995-09-18 | a50c72e98297… |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 |
|---|---|---|---|---|---|---|
| Mupirocin | MUPIROCIN CALCIUM | REMEDYREPACK INC. | 9a1be092-6fe8-4b7c-a668-e584783f888b | 2026-06-05 | Warnings, Adverse reactions | MUPIROCIN CALCIUM |
| Mupirocin | MUPIROCIN CALCIUM | Sun Pharmaceutical Industries, Inc. | 6719ffba-3430-4fa9-b65b-c5c195ee1b35 | 2026-04-10 | Warnings, Adverse reactions | MUPIROCIN CALCIUM |
| Mupirocin | MUPIROCIN CALCIUM | NORTHSTAR RX LLC | 6f1c0789-4a3b-473a-96d6-0c479ee32d36 | 2026-04-10 | Warnings, Adverse reactions | MUPIROCIN CALCIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.