Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018345
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NPH ILETIN II (PORK) INSULIN SUSP ISOPHANE PURIFIED PORK 100 UNITS/ML 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
12/05/1979 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/11/2006 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018344s026,018345s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018344s026_018345s027ltr.pdf
10/29/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1997 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1996 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/07/1992 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1992 SUPPL-18 Labeling

Label is not available on this site.

03/12/1991 SUPPL-16 Labeling

Label is not available on this site.

09/24/1990 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1989 SUPPL-13 Labeling

Label is not available on this site.

02/27/1989 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1988 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1987 SUPPL-10 Labeling

Label is not available on this site.

04/28/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1985 SUPPL-7 Labeling

Label is not available on this site.

02/28/1984 SUPPL-6 Labeling

Label is not available on this site.

11/23/1984 SUPPL-5 Labeling

Label is not available on this site.

06/13/1983 SUPPL-4 Labeling

Label is not available on this site.

09/21/1982 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/19/1981 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
01/11/2006 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018344s026,018345s027lbl.pdf

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