Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072640
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM;TOPICAL Prescription AB No 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
08/31/1993 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2009 SUPPL-31 Labeling

Label is not available on this site.

11/04/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/2001 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/2001 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/24/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/2001 SUPPL-22 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/24/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1999 SUPPL-17 Labeling

Label is not available on this site.

06/23/1999 SUPPL-16 Labeling

Label is not available on this site.

06/23/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/23/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/29/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/08/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/09/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/24/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/01/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/28/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/14/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/15/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLOTRIMAZOLE

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM;TOPICAL Prescription No AB 078338 FOUGERA PHARMS
CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM;TOPICAL Prescription No AB 090219 GLENMARK PHARMS
CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM;TOPICAL Prescription No AB 072640 TARO

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