Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076335
Company: VINTAGE PHARMS LLC
Company: VINTAGE PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRI-PREVIFEM | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,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 |
|---|---|---|---|---|---|---|---|
| 03/26/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076335_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-21 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/03/2022 | SUPPL-20 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/24/2016 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2014 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/24/2016 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/03/2013 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |