Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201512
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PIRMELLA 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | 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 |
|---|---|---|---|---|---|---|---|
| 04/24/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/2019 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/22/2019 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/22/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/13/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |