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
ALDARA از شرکت BAUSCH
New Drug Application (NDA): 020723
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALDARA | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription |
AB |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/27/1997 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/03/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/2010 | SUPPL-22 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020723s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020723s022ltr.pdf |
||
| 03/22/2007 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020723s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020723s020LTR.pdf |
||
| 08/09/2005 | SUPPL-18 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020723s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020723s018ltr.pdf |
||
| 07/14/2004 | SUPPL-16 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20723s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020723_S016_ALDARA_CREAM.pdf |
||
| 03/02/2004 | SUPPL-15 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723se1-015_aldara_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20723se1-015ltr.pdf |
||
| 09/03/2002 | SUPPL-12 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr011,012ltr.pdf |
||
| 09/03/2002 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr011,012ltr.pdf |
||
| 12/15/2002 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr010ltr.pdf |
||
| 03/28/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/2001 | SUPPL-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20723s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020723Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/14/2010 | SUPPL-22 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020723s022lbl.pdf | |
| 03/22/2007 | SUPPL-20 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020723s020lbl.pdf | |
| 08/09/2005 | SUPPL-18 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020723s018lbl.pdf | |
| 07/14/2004 | SUPPL-16 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723s016lbl.pdf | |
| 03/02/2004 | SUPPL-15 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723se1-015_aldara_lbl.pdf | |
| 12/15/2002 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf | |
| 09/03/2002 | SUPPL-12 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf | |
| 09/03/2002 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf | |
| 12/08/2001 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20723s1lbl.pdf |
ALDARA
CREAM;TOPICAL; 5%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALDARA | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | Yes | AB | 020723 | BAUSCH |
| IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | No | AB | 091308 | APOTEX INC |
| IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | No | AB | 078548 | FOUGERA PHARMS |
| IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | No | AB | 201994 | GLENMARK GENERICS |
| IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | No | AB | 078837 | PERRIGO ISRAEL |
| IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | No | AB | 200173 | TARO |
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