Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019617
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREPIDIL | DINOPROSTONE | 0.5MG/3GM | GEL;ENDOCERVICAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/09/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/03/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/05/2017 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019617s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019617Orig1s017ltr.pdf | |
09/10/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/12/2010 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019617s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019617s010ltr.pdf | |
04/26/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/07/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/13/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
02/27/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/05/2017 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019617s017lbl.pdf | |
02/12/2010 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019617s010lbl.pdf |