Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091212
Company: KRKA TOVARNA ZDRAVIL
Company: KRKA TOVARNA ZDRAVIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | No | No |
| LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 09/16/2013 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |