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 | Yes |
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. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
03/18/2022 | SUPPL-4 | Labeling-Package Insert |
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 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 205069 | XIROMED |
TRI-LEGEST FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 076105 | BARR |