Drugs@FDA: FDA Approved Drug Products

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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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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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