Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 019676
Company: GENENTECH
Company: GENENTECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUTROPIN | SOMATROPIN [rDNA origin] | N/A | Injectable; Injection | Prescription | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/13/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf | |
| 04/10/2012 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019676s042lbl.pdf | |
| 02/15/2007 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf | |
| 02/23/2006 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019676s026lbl.pdf | |
| 06/28/2005 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf | |
| 06/28/2005 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf | |
| 06/28/2005 | SUPPL-20 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf | |
| 06/28/2005 | SUPPL-20 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf | |
| 04/13/2000 | SUPPL-16 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676S016_Nutropin_prntlbl.pdf |