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): 021007
Company: GLAXOSMITHKLINE
| 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 |
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21007lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/04/2005 | SUPPL-17 | Labeling |
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 |
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 |
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 |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf |
|
| 08/02/2002 | SUPPL-11 | Labeling |
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 |
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 |
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/2005/021007s017lbl.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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