Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021396
Company: WYETH AYERST
Company: WYETH AYERST
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREMPRO/PREMPHASE | CONJUGATED ESTROGENS/MEDROXYPROGESTERONE ACETATE | 0.45MG/1.5MG & 0.3MG/1.5MG | Tablet; Oral | Prescription | 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 |
---|---|---|---|---|---|---|---|
06/04/2003 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21396_prempro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21396ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-396_Prempro.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/04/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21396_prempro_lbl.pdf |