Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216919
Company: MANKIND PHARMA LTD
Company: MANKIND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SITAGLIPTIN | SITAGLIPTIN PHOSPHATE | 25MG | TABLET; FILM COATED | Prescription | None | No | No |
SITAGLIPTIN | SITAGLIPTIN PHOSPHATE | 50MG | TABLET; FILM COATED | Prescription | None | No | No |
SITAGLIPTIN | SITAGLIPTIN PHOSPHATE | 100MG | TABLET; FILM COATED | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/02/2024 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216919Orig1s000TA_ltr.pdf |