Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022351
Company: AR HOLDING CO INC
Company: AR HOLDING CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLCRYS | COLCHICINE | 0.6MG | TABLET; ORAL | Prescription | None | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 07/30/2009 | ORIG-1 | Approval | Type 7 - Drug Already Marketed without Approved NDA | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022351lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022351s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022351_colcrys_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022351s000_SumR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/30/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022351lbl.pdf |