Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207055
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYONANZ | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | 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 |
|---|---|---|---|---|---|---|---|
| 10/21/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CYONANZ
TABLET;ORAL-28; 0.035MG;0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYONANZ | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 207055 | AUROBINDO PHARMA LTD |
| NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 070686 | MAYNE PHARMA |
| NORTREL 0.5/35-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 072695 | BARR |
| WERA | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 091204 | NOVAST LABS LTD |
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