Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208335
Company: SUNSHINE
Company: SUNSHINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LINAGLIPTIN | LINAGLIPTIN | 5MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/31/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208335Orig1s000ltr.pdf |
LINAGLIPTIN
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LINAGLIPTIN | LINAGLIPTIN | 5MG | TABLET;ORAL | Prescription | No | AB | 208335 | SUNSHINE |
TRADJENTA | LINAGLIPTIN | 5MG | TABLET;ORAL | Prescription | Yes | AB | 201280 | BOEHRINGER INGELHEIM |