Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018827
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTRISONE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM;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
07/10/1984 ORIG-1 Approval Type 4 - New Combination 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
06/14/2019 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018827s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018827Orig1s050ltr.pdf
05/21/2018 SUPPL-49 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018827s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018827Orig1s049,019543Orig1s028,019625Orig1s026,019796Orig1s029ltr.pdf
04/21/2014 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018827s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018827Orig1s046ltr.pdf
05/11/2009 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018827s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018827s042ltr.pdf
01/25/2008 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018827s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018827s038ltr.pdf
03/27/2003 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18827slr025_lotrisone_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18827slr025ltr.pdf
01/10/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-22 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18827s22ltr.pdf
02/28/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-20 Labeling

Label is not available on this site.

02/02/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1998 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/18/1998 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1998 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/06/1994 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/03/2001 SUPPL-9 Labeling

Label is not available on this site.

09/11/1990 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-7 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s7s9s20s22lbl.pdf
08/01/1990 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/12/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/22/1985 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
06/14/2019 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018827s050lbl.pdf
05/21/2018 SUPPL-49 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018827s049lbl.pdf
05/21/2018 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018827s049lbl.pdf
04/21/2014 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018827s046lbl.pdf
05/11/2009 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018827s042lbl.pdf
01/25/2008 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018827s038lbl.pdf
03/27/2003 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18827slr025_lotrisone_lbl.pdf
10/03/2001 SUPPL-22 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s22lbl.pdf
10/03/2001 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s7s9s20s22lbl.pdf

LOTRISONE

CREAM;TOPICAL; EQ 0.05% BASE;1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM;TOPICAL Prescription No AB 076002 ACTAVIS MID ATLANTIC
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM;TOPICAL Prescription No AB 075502 FOUGERA PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM;TOPICAL Prescription No AB 202894 GLENMARK PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM;TOPICAL Prescription No AB 075673 TARO
LOTRISONE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM;TOPICAL Prescription Yes AB 018827 MERCK SHARP DOHME

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