Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
SITAGLIPTIN PHOSPHATE | A215155 | ALKEM LABS LTD
47 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| Date | Submission | Document |
|---|---|---|
| Jun 2, 2026 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.