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 SOLUSPAN از شرکت MERCK SHARP DOHME
New Drug Application (NDA): 014602
Company: MERCK SHARP DOHME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CELESTONE SOLUSPAN | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/03/1965 | 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 |
|---|---|---|---|---|---|
| 04/10/2018 | SUPPL-62 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014602s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/014602Orig1s062ltr.pdf |
||
| 02/09/2018 | SUPPL-61 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014602s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/014602Orig1s061ltr.pdf |
||
| 02/04/2015 | SUPPL-59 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/014602s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/014602Orig1s059ltr.pdf |
||
| 07/03/2014 | SUPPL-58 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014602Orig1s058lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014602Orig1s058ltredt.pdf |
||
| 05/21/2014 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2013 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/014602Orig1s056.pdf |
|
| 01/09/2013 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/2008 | SUPPL-47 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/014602s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/014602s047ltr.pdf |
||
| 07/24/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/08/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/15/1999 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1997 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/13/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/2006 | SUPPL-19 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014602s019ltr.pdf |
|
| 05/03/1995 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/14/1994 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/07/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/17/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/06/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1987 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/10/2018 | SUPPL-62 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014602s062lbl.pdf | |
| 02/09/2018 | SUPPL-61 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014602s061lbl.pdf | |
| 02/04/2015 | SUPPL-59 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/014602s059lbl.pdf | |
| 07/03/2014 | SUPPL-58 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014602Orig1s058lbledt.pdf | |
| 06/24/2008 | SUPPL-47 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/014602s047lbl.pdf |
CELESTONE SOLUSPAN
INJECTABLE;INJECTION; 3MG/ML;EQ 3MG BASE/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AB | 090747 | AM REGENT |
| CELESTONE SOLUSPAN | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 014602 | MERCK SHARP DOHME |
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