Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091674
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | 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 |
|---|---|---|---|---|---|---|---|
| 10/26/2011 | 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 |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/24/2023 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/24/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2013 | SUPPL-2 | Labeling-Package Insert, Labeling-Proprietary Name Change |
Label is not available on this site. |
||
| 02/27/2013 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
TABLET;ORAL; 0.02MG,0.1MG;0.01MG,N/A
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 091674 | LUPIN LTD |
| LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 200493 | MYLAN LABS LTD |
| LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 205131 | XIROMED |
| LO SIMPESSE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 206852 | AUROBINDO PHARMA |
| LOSEASONIQUE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 022262 | TEVA BRANDED PHARM |