Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076387
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOTRIMAZOLE CLOTRIMAZOLE 10MG TROCHE/LOZENGE;ORAL 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
07/29/2004 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76387ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076387_Clotrimazole LozengesTOC.cfm

CLOTRIMAZOLE

TROCHE/LOZENGE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOTRIMAZOLE CLOTRIMAZOLE 10MG TROCHE/LOZENGE;ORAL Prescription No AB 076763 PADDOCK LLC
CLOTRIMAZOLE CLOTRIMAZOLE 10MG TROCHE/LOZENGE;ORAL Prescription No AB 076387 WEST-WARD PHARMS INT

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