Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076334
Company: PH HEALTH
Company: PH HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREVIFEM | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.25MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/09/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076334_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-24 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/03/2022 | SUPPL-23 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/24/2016 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2014 | SUPPL-20 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/24/2016 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2013 | SUPPL-17 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |