Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021214
Company: SUCAMPO PHARMA LLC
Company: SUCAMPO PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RESCULA | UNOPROSTONE ISOPROPYL | 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/03/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21214lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21214ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21214_Rescula.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/10/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/2012 | SUPPL-7 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s007.pdf | |
| 12/07/2012 | SUPPL-6 | Manufacturing (CMC) |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s006.pdf | |
| 12/05/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/07/2012 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf | |
| 12/07/2012 | SUPPL-6 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf |
| 08/03/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21214lbl.pdf |