Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072723
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOVIA 1/50E-28 | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.05MG;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 |
|---|---|---|---|---|---|---|---|
| 12/30/1991 | 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-44 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/01/2017 | SUPPL-38 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/07/2017 | SUPPL-37 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/20/2004 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/30/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/29/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/30/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/10/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/27/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/12/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
ZOVIA 1/50E-28
TABLET;ORAL-28; 0.05MG;1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.05MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 204704 | MYLAN LABS LTD |
| MALMOREDE | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.05MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 209547 | NOVAST LABS |
| ZOVIA 1/50E-28 | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.05MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 072723 | WATSON LABS |