Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074580
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION;TOPICAL Prescription AT 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
07/29/1996 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
09/11/2003 SUPPL-6 Labeling

Label is not available on this site.

11/04/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

CLOTRIMAZOLE

SOLUTION;TOPICAL; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION;TOPICAL Prescription No AT 209815 NOVITIUM PHARMA
CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION;TOPICAL Prescription No AT 074580 TARO
CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION;TOPICAL Prescription No AT 212281 TASMAN PHARMA
CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION;TOPICAL Prescription No AT 073306 TEVA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English