Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018741
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 OINTMENT, AUGMENTED;TOPICAL 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
07/27/1983 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-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018741s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018741Orig1s040;019555Orig1s035;019716Orig1s033ltr.pdf
03/28/2018 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018741s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018741Orig1s038,019555Orig1s034,019716Orig1s032ltr.pdf
08/13/2014 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018741s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf
08/28/2006 SUPPL-28 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s028LTR.pdf
11/10/1998 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/15/1998 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1998 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1998 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/2005 SUPPL-16 Labeling Label (PDF)
Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018741s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018741s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s016ltr.pdf
11/08/1991 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1990 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1989 SUPPL-13 Labeling

Label is not available on this site.

11/30/1988 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/12/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/22/1985 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/16/1984 SUPPL-3 Labeling

Label is not available on this site.

12/15/1983 SUPPL-2 Labeling

Label is not available on this site.

09/29/1986 SUPPL-1 Labeling

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-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018741s040lbl.pdf
03/28/2018 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018741s038lbl.pdf
08/13/2014 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018741s036lbl.pdf
08/28/2006 SUPPL-28 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s028lbl.pdf
10/07/2005 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s016lbl.pdf
10/07/2005 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018741s016lbl.pdf

DIPROLENE

OINTMENT, AUGMENTED;TOPICAL; EQ 0.05% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT, AUGMENTED;TOPICAL Prescription No AB 074304 ACTAVIS MID ATLANTIC
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT, AUGMENTED;TOPICAL Prescription No AB 075373 FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT, AUGMENTED;TOPICAL Prescription No AB 076753 TARO
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT, AUGMENTED;TOPICAL Prescription No AB 206118 TELIGENT PHARMA INC
DIPROLENE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE OINTMENT, AUGMENTED;TOPICAL Prescription Yes AB 018741 MERCK SHARP DOHME

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