Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020168
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUTROPIN SOMATROPIN 5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
NUTROPIN SOMATROPIN 10MG/VIAL INJECTABLE;INJECTION Discontinued 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
11/17/1993 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2016 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019676Orig1s044,020168Orig1s024ltr.pdf
09/17/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/02/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/28/2000 SUPPL-16 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020168_S016&020656_S005_NUTROPIN FOR INJ.pdf
11/03/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/25/1998 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1998 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1996 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/21/1995 SUPPL-10 Labeling

Label is not available on this site.

02/01/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/05/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/22/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1995 SUPPL-6 Labeling

Label is not available on this site.

08/03/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/21/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/15/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/15/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/13/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf

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