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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014602
Company: ORGANON

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
09/06/2022 SUPPL-65 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/014602Orig1s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/014602Orig1s065ltr.pdf
04/10/2018 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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) Review (PDF)

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

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
09/06/2022 SUPPL-65 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/014602Orig1s065lbl.pdf
09/06/2022 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/014602Orig1s065lbl.pdf
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
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE;INJECTION Prescription No AB 077838 HIKMA
CELESTONE SOLUSPAN BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE;INJECTION Prescription Yes AB 014602 ORGANON
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