Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202962
Company: NOVAST LABS
Company: NOVAST LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHABELINA FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/15/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CHABELINA FE
TABLET;ORAL-28; 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHABELINA FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 202962 | NOVAST LABS |
| ESTROSTEP FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | TABLET;ORAL-28 | Prescription | Yes | AB | 020130 | APIL |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 076629 | MAYNE PHARMA |
| TRI-LEGEST FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 076105 | BARR |
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