Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021430
Company: CELGENE
Company: CELGENE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THALOMID | THALIDOMIDE | 50MG | CAPSULE; ORAL | Prescription | None | No | No |
THALOMID | THALIDOMIDE | 100MG | CAPSULE; ORAL | Prescription | None | No | No |
THALOMID | THALIDOMIDE | 200MG | CAPSULE; 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 |
---|---|---|---|---|---|---|---|
05/25/2006 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021430s000, 020785s031LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021430s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/25/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430lbl.pdf |