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 SCHERING
New Drug Application (NDA): 017561
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CELESTONE | BETAMETHASONE SODIUM PHOSPHATE | EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/1974 | 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 |
|---|---|---|---|---|---|
| 05/19/2003 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/15/1999 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1999 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/11/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/13/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/2003 | SUPPL-13 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17561slr013ltr.pdf |
|
| 04/13/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/14/1994 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/07/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/17/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/06/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1987 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1987 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/07/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1978 | SUPPL-1 | Labeling |
Label is not available on this site. |
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