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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014215
Company: MERCK SHARP DOHME

Products on NDA 014215

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 014215

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.

Labels for NDA 014215

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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