CELESTONE از شرکت SCHERING

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BETAMETHASONE SODIUM PHOSPHATE EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued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

Letter (PDF)

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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