Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214226
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TENOFOVIR ALAFENAMIDE | TENOFOVIR ALAFENAMIDE FUMARATE | EQ 25MG BASE | 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 |
---|---|---|---|---|---|---|---|
03/30/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214226Orig1s000ltr.pdf |
TENOFOVIR ALAFENAMIDE
TABLET;ORAL; EQ 25MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TENOFOVIR ALAFENAMIDE | TENOFOVIR ALAFENAMIDE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 214226 | LUPIN LTD |
VEMLIDY | TENOFOVIR ALAFENAMIDE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | Yes | AB | 208464 | GILEAD SCIENCES INC |