Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020874
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LUNELLE | ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE | 5MG/0.5ML;25MG/0.5ML | INJECTABLE;INTRAMUSCULAR | 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 |
---|---|---|---|---|---|---|---|
10/05/2000 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20874lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20874ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-874_Lunelle.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/26/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/07/2001 | 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 |
---|---|---|---|---|---|
10/05/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20874lbl.pdf |