Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072721
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOVIA 1/35E-28 | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.035MG;1MG | TABLET;ORAL-28 | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/30/1991 | 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-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2017 | SUPPL-36 | 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. |
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| 09/11/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/30/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/10/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 09/27/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/12/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |