AGENERASE از شرکت GLAXOSMITHKLINE

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AGENERASE از شرکت GLAXOSMITHKLINE

New Drug Application (NDA): 021039

Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AGENERASE AMPRENAVIR 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;ORAL Discontinued

None

Yes 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
04/15/1999 ORIG-1 Approval

Type 3 – New Dosage Form

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-007_Agenerase_prntlbl.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/2005/021039s017lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021039s017ltr.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

12/24/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

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

10/02/2002 SUPPL-13 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-12 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-10 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-9 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-8 Labeling

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.

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/2005/021039s017lbl.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-14

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf
10/02/2002 SUPPL-13

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf
08/02/2002 SUPPL-10

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/nda/99/21-007_Agenerase_prntlbl.pdf
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