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
BECONASE AQ از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 019389
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BECONASE AQ | BECLOMETHASONE DIPROPIONATE MONOHYDRATE | EQ 0.042MG DIPROP/SPRAY | SPRAY, METERED;NASAL | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 07/27/1987 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 04/12/2019 | SUPPL-34 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019389Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019389Orig1s034ltr.pdf |
||
| 06/17/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/2005 | SUPPL-27 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019389s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019389s027ltr.pdf |
||
| 03/04/2002 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/16/2002 | SUPPL-25 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19389slr025ltr.pdf |
|
| 07/09/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/2001 | SUPPL-23 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19389s23lbl.pdf |
||
| 12/19/2002 | SUPPL-21 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19389slr021ltr.pdf |
|
| 02/24/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/26/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/19/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/10/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1992 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1989 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/09/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/08/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1989 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/19/1988 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/12/2019 | SUPPL-34 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019389Orig1s034lbl.pdf | |
| 10/27/2005 | SUPPL-27 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019389s027lbl.pdf | |
| 08/31/2001 | SUPPL-23 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19389s23lbl.pdf |
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