Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019555
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPROLENE AF BETAMETHASONE DIPROPIONATE EQ 0.05% BASE CREAM, 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
04/27/1987 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-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019555s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018741Orig1s040;019555Orig1s035;019716Orig1s033ltr.pdf
03/28/2018 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019555s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018741Orig1s038,019555Orig1s034,019716Orig1s032ltr.pdf
08/13/2014 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019555s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf
08/28/2006 SUPPL-26 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019555s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019555s026ltr.pdf
04/04/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-16 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19555s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-555S008_Diprosone.cfm
08/14/2000 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

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

Label is not available on this site.

11/10/1998 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19555s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-555S008_Diprosone.cfm
06/29/1990 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1990 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1989 SUPPL-5 Labeling

Label is not available on this site.

11/08/1988 SUPPL-4 Labeling

Label is not available on this site.

10/29/1987 SUPPL-2 Manufacturing (CMC)

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-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019555s035lbl.pdf
03/28/2018 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019555s034lbl.pdf
08/13/2014 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019555s033lbl.pdf
08/28/2006 SUPPL-26 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019555s026lbl.pdf
10/03/2001 SUPPL-16 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf
10/03/2001 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf

DIPROLENE AF

CREAM, 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 CREAM, AUGMENTED;TOPICAL Prescription No AB 076603 ANDA REPOSITORY
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE CREAM, AUGMENTED;TOPICAL Prescription No AB 076215 FOUGERA PHARMS
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE CREAM, AUGMENTED;TOPICAL Prescription No AB 078930 GLENMARK GENERICS
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE CREAM, AUGMENTED;TOPICAL Prescription No AB 076592 PERRIGO ISRAEL
BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE CREAM, AUGMENTED;TOPICAL Prescription No AB 076543 TARO
DIPROLENE AF BETAMETHASONE DIPROPIONATE EQ 0.05% BASE CREAM, AUGMENTED;TOPICAL Prescription Yes AB 019555 MERCK SHARP DOHME

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English