Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072641
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM;VAGINAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/04/1995 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
11/04/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/2001 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2000 SUPPL-14 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/14/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2000 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/14/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2000 SUPPL-10 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/29/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/08/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/30/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/25/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/25/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLOTRIMAZOLE

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

CREAM;VAGINAL; 1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM;VAGINAL Over-the-counter No 074165 P AND L
CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM;VAGINAL Over-the-counter No 072641 TARO

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