Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090948
Company: NOVAST LABS LTD
Company: NOVAST LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DASETTA 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;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 |
|---|---|---|---|---|---|---|---|
| 12/22/2011 | ORIG-1 | Approval |
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-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/16/2022 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2022 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DASETTA 1/35
TABLET;ORAL-28; 0.035MG;1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALYACEN 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 091634 | GLENMARK PHARMS LTD |
| DASETTA 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 090948 | NOVAST LABS LTD |
| NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 206864 | NAARI PTE LTD |
| NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 070687 | WATSON LABS TEVA |
| NORTREL 1/35-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 072696 | BARR |
| NYLIA 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 207056 | AUROBINDO PHARMA |