Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076104
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription AB 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
05/28/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76104ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2015 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/17/2015 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

02/20/2013 SUPPL-11 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

03/29/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/12/2011 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

ITRACONAZOLE

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 205991 ACCORD HLTHCARE
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 206741 ALEMBIC PHARMS LTD
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 208591 ALKEM LABS LTD
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 205080 AMNEAL PHARMS
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 203445 JUBILANT GENERICS
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 200463 MYLAN PHARMS INC
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 205724 PAR PHARM INC
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 206410 PII
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 076104 SANDOZ
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 209460 TORRENT
ITRACONAZOLE ITRACONAZOLE 100MG CAPSULE;ORAL Prescription No AB 204672 ZYDUS PHARMS
SPORANOX ITRACONAZOLE 100MG CAPSULE;ORAL Prescription Yes AB 020083 JANSSEN PHARMS

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