Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020889
Company: SCHERING PLOUGH

Products on NDA 020889

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOTRIMIN AF	CLOTRIMAZOLE	1%	Lotion; Topical	Over-the-counter	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020889

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/1989	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
03/07/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
10/04/1999	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/01/2001	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20889s2lbl.pdf
05/19/1998	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020889

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2001	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20889s2lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

LOTRIMIN AF

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

Lotion; Topical; 1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LOTRIMIN AF	CLOTRIMAZOLE	1%	Lotion; Topical	Over-the-counter	Yes	020889	SCHERING PLOUGH