Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 206053
Company: MYLAN LABS LTD
Company: MYLAN LABS 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,0.15MG; 0.025MG,0.15MG;0.03MG,0.15MG; 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 |
|---|---|---|---|---|---|---|---|
| 10/02/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
TABLET;ORAL; 0.02MG,0.15MG; 0.025MG,0.15MG;0.03MG,0.15MG; 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,0.15MG; 0.025MG,0.15MG;0.03MG,0.15MG; 0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 206053 | MYLAN LABS LTD |
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