Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019796
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELOCON MOMETASONE FUROATE 0.1% LOTION;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
03/30/1989 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
05/21/2018 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019796s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018827Orig1s049,019543Orig1s028,019625Orig1s026,019796Orig1s029ltr.pdf
03/28/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019796s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019796Orig1s026ltr.pdf
09/09/2005 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019796s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019796s020ltr.pdf
07/17/2002 SUPPL-15 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19796slr008,se5-015ltr.pdf
07/13/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/2000 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/02/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/17/2002 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19796slr008,se5-015ltr.pdf
04/16/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/11/1992 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/1991 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1989 SUPPL-1 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
05/21/2018 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019796s029lbl.pdf
03/28/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019796s026lbl.pdf
09/09/2005 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019796s020lbl.pdf
07/17/2002 SUPPL-15 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf
07/17/2002 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf

ELOCON

LOTION;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELOCON MOMETASONE FUROATE 0.1% LOTION;TOPICAL Prescription Yes AB 019796 MERCK SHARP DOHME
MOMETASONE FUROATE MOMETASONE FUROATE 0.1% LOTION;TOPICAL Prescription No AB 077678 COSETTE
MOMETASONE FUROATE MOMETASONE FUROATE 0.1% LOTION;TOPICAL Prescription No AB 075919 FOUGERA PHARMS
MOMETASONE FUROATE MOMETASONE FUROATE 0.1% LOTION;TOPICAL Prescription No AB 090506 GLENMARK GENERICS
MOMETASONE FUROATE MOMETASONE FUROATE 0.1% LOTION;TOPICAL Prescription No AB 077180 PERRIGO ISRAEL
MOMETASONE FUROATE MOMETASONE FUROATE 0.1% LOTION;TOPICAL Prescription No AB 076788 TARO

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