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 از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 018584
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BECONASE | BECLOMETHASONE DIPROPIONATE | 0.042MG/INH | AEROSOL, METERED;NASAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1981 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
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 |
|---|---|---|---|---|---|
| 02/20/2002 | SUPPL-28 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/31/2001 | SUPPL-27 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18584s27lbl.pdf |
||
| 12/16/2002 | SUPPL-26 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18584slr026ltr.pdf |
|
| 04/04/1996 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/12/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 07/06/1993 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/10/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/15/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/27/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1987 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/06/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1985 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/04/1985 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/01/1985 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/01/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/15/1984 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/24/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/16/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/16/1988 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/31/2001 | SUPPL-27 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18584s27lbl.pdf |
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