Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075548
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MICROGESTIN 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Discontinued | None | No | No |
| MICROGESTIN FE 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/05/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75548ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075548Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/31/2021 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/07/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/23/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/24/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |