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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021007
Company: GLAXOSMITHKLINE

Products on NDA 021007

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AGENERASE	AMPRENAVIR	50MG	CAPSULE;ORAL	Discontinued	None	No	No
AGENERASE	AMPRENAVIR	150MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021007

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/1999	ORIG-1	Approval	Type 1 - New Molecular Entity		Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-007_Agenerase_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21007&21039_Agenerase.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2005	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021007s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021007s017ltr.pdf
02/12/2004	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21007slr016,21039slr016_agenerase_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21007slr016,21039slr016ltr.pdf
10/02/2002	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039slr013,014ltr.pdf
10/02/2002	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039slr013,014ltr.pdf
02/05/2002	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf
08/02/2002	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s11,21039s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr011and21039slr010ltr.pdf
02/05/2002	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf
05/09/2001	SUPPL-9	Labeling		Label is not available on this site.
12/14/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/11/2001	SUPPL-6		Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007S006_Agenerase.cfm
12/19/2000	SUPPL-5	Labeling		Label is not available on this site.
12/22/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/24/2000	SUPPL-3	Labeling		Label is not available on this site.
04/28/2000	SUPPL-2	Labeling		Label is not available on this site.
09/22/1999	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 021007

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2005	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021007s017lbl.pdf
02/12/2004	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21007slr016,21039slr016_agenerase_lbl.pdf
10/02/2002	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf
10/02/2002	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf
08/02/2002	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s11,21039s10lbl.pdf
05/11/2001	SUPPL-6	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Prntlbl.pdf
04/15/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21007lbl.pdf

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