Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019716
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPROLENE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE LOTION, AUGMENTED;TOPICAL 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
08/01/1988 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
05/01/2019 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019716s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018741Orig1s040;019555Orig1s035;019716Orig1s033ltr.pdf
03/28/2018 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019716s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018741Orig1s038,019555Orig1s034,019716Orig1s032ltr.pdf
08/13/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019716s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf
08/28/2006 SUPPL-22 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019716s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s022ltr.pdf
04/24/2006 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s021LTR.pdf
05/11/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/2000 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1998 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1998 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/07/2005 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019716s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019716s006ltr.pdf
07/01/1992 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1990 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1989 SUPPL-3 Labeling

Label is not available on this site.

04/06/1989 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/01/2019 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019716s033lbl.pdf
03/28/2018 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019716s032lbl.pdf
08/13/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019716s030lbl.pdf
08/28/2006 SUPPL-22 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019716s022lbl.pdf
10/07/2005 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019716s006lbl.pdf

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