Sandoz
Generic drug makerAI in SwitzerlandAI. FDA records under 6 spellings of its name, each linked to the record. See the Sandoz group view.
- Records across the group: 783, 9 entitiesAI
- Drug applications: 693
- Drug recalls: 67
- 510(k) clearances: 20
- Complete response letters: 3
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Sandoz and its 8 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Dec 9, 2025 | Complete response letter, BLA 761271Unapproved | Complete response letters |
| Dec 5, 2024 | Complete response letter, BLA 761271Unapproved | Complete response letters |
| Jun 24, 2016 | Complete response letter, BLA 761045Approved | Complete response letters |
| Jun 7, 2012 | Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc.,Class III · Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may b | Drug recalls |
| Mar 18, 1997 | COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)K965087 · KNT | 510(k) clearances |
| Oct 4, 1996 | COMPAT NASOJEJUNAL FEEDING TUBEK961664 · KNT | 510(k) clearances |
| Feb 1, 1995 | SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATIONK940555 · LZH | 510(k) clearances |
| Nov 7, 1994 | SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMPK940556 · LZH | 510(k) clearances |
| Jul 29, 1993 | GASTROPORT IIK924308 · KNT | 510(k) clearances |
| Apr 6, 1993 | PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KITK923983 · KNT | 510(k) clearances |
| Mar 12, 1993 | PEG GASTROSTOMY TUBE KITK915308 · FPD | 510(k) clearances |
| Jan 4, 1993 | PEG PREP TRAYK920493 · KNT | 510(k) clearances |
Subsidiaries and Divisions
8 firms in the Sandoz group, most records first- Fougera Pharmaceuticals Inc.95 records
- Savage Laboratories34 records
- Pharmaderm26 records
- Fougera25 records
- Sandoz Nutrition20 records
- Ebewe Pharma3 records
- Lek Pharmaceuticals3 records
- Sandoz Canada2 records
Canada and Imports
Across the Sandoz group, matched by company name- FDA import refusals since 2024
- 35 shipment lines, through Oct 23, 2026
Names and Identifiers
- Appears as
- Website
- sandoz.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built