Active ingredient
Lanreotide
13 finished FDA listings contain Lanreotide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LANREOTIDE ACETATE
- Dosage forms
- Injection
- Routes
- Subcutaneous
- Manufacturers / labelers
- 4
- Strengths listed
- 120 mg/.5ml · 60 mg/.2ml · 90 mg/.3ml
- Brand names in FDA listings
- Somatuline Depot
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 68092
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022074 | IPSEN PHARMA | 2007-08-30 | 3 |
| NDA 215395 | INVAGEN PHARMS | 2021-12-17 | 3 |
| ANDA 217193 | INVAGEN PHARMS | 2024-05-21 | 6 |
| ANDA 218217 | AMNEAL | 2026-09-18 | 1 |
Official labeling on DailyMed
- LANREOTIDE ACETATE INJECTION [CIPLA USA INC.] · version 3 · 2025-06-02
- LANREOTIDE ACETATE INJECTION [EXELAN PHARMACEUTICALS, INC.] · version 2 · 2025-06-02
- SOMATULINE DEPOT (LANREOTIDE ACETATE) INJECTION [IPSEN BIOPHARMACEUTICALS, INC.] · version 16 · 2024-10-17
- LANREOTIDE ACETATE INJECTION [CIPLA USA INC.] · version 7 · 2024-09-25
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.