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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078058
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANASTROZOLE ANASTROZOLE 1MG TABLET;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
06/28/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078058s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2024 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.

10/28/2020 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

07/23/2015 SUPPL-8 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

07/23/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/08/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/22/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

ANASTROZOLE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 090568 ACCORD HLTHCARE
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 206037 BEIJING YILING
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 091164 CIPLA
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 212434 EUGIA PHARMA
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 078944 KENTON
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 079220 NATCO PHARMA LTD
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 078058 TEVA PHARMS
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 078921 ZYDUS PHARMS USA INC
ARIMIDEX ANASTROZOLE 1MG TABLET;ORAL Prescription Yes AB 020541 ANI PHARMS
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