Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016931
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
R-GENE 10 ARGININE HYDROCHLORIDE 10GM/100ML INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/28/1973 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
01/17/2010 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016931s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016931s031ltr.pdf
08/13/2003 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16931slr028_r-gene_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16931slr028ltr.pdf
04/11/2000 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/15/1995 SUPPL-26 Labeling

Label is not available on this site.

03/17/1993 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1991 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1990 SUPPL-23 Labeling

Label is not available on this site.

10/24/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/05/1986 SUPPL-21 Labeling

Label is not available on this site.

07/29/1985 SUPPL-20 Labeling

Label is not available on this site.

05/09/1984 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/19/1985 SUPPL-18 Labeling

Label is not available on this site.

01/11/1982 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1980 SUPPL-14 Labeling

Label is not available on this site.

10/01/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1975 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/17/2010 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016931s031lbl.pdf
08/13/2003 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16931slr028_r-gene_lbl.pdf

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