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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020073
Company: HOFFMANN LA ROCHE

Products on NDA 020073

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROMAZICON	FLUMAZENIL	1MG/10ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
ROMAZICON	FLUMAZENIL	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020073

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/1991	ORIG-1	Approval	Type 1 - New Molecular Entity	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
10/04/2007	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020073s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020073s016ltr.pdf
11/12/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/06/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
03/03/2004	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020073s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20073slr011ltr.pdf
05/22/2000	SUPPL-10	Labeling		Label is not available on this site.
11/14/1997	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
09/21/1998	SUPPL-8	Labeling		Label is not available on this site.
07/12/1994	SUPPL-7	Labeling		Label is not available on this site.
12/05/1994	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
11/29/1994	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
05/10/1995	SUPPL-4	Labeling		Label is not available on this site.
10/24/1995	SUPPL-3	Labeling		Label is not available on this site.
12/15/1992	SUPPL-2	Labeling		Label is not available on this site.
09/11/1992	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020073

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/04/2007	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020073s016lbl.pdf
03/03/2004	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020073s011lbl.pdf

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