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
CELESTONE از شرکت MERCK SHARP DOHME
New Drug Application (NDA): 014215
Company: MERCK SHARP DOHME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CELESTONE | BETAMETHASONE | 0.6MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 04/13/1964 | 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 |
|---|---|---|---|---|---|
| 07/27/2000 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1999 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1998 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/2006 | SUPPL-15 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014215s009s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014215s009, s015ltr.pdf |
||
| 09/10/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/10/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/17/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/12/2006 | SUPPL-9 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014215s009s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014215s009, s015ltr.pdf |
||
| 04/19/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1987 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1978 | SUPPL-4 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/12/2006 | SUPPL-15 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014215s009s015lbl.pdf | |
| 07/12/2006 | SUPPL-9 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014215s009s015lbl.pdf |
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