Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019500
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMPRENE | CLOFAZIMINE | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
| LAMPRENE | CLOFAZIMINE | 50MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/31/2019 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019500s014lbl.pdf | |
| 07/08/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019500s013lbl.pdf |
| 06/11/2003 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19500slr010_lamprene_lbl.pdf |