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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016931
Company: PHARMACIA AND UPJOHN

Products on NDA 016931

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016931

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.

Labels for NDA 016931

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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