Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075471
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUPROLIDE ACETATE LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE;INJECTION Prescription AP 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
10/25/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75471ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2017 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

05/19/2017 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

05/19/2017 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

01/31/2013 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

08/09/2012 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

03/28/2011 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

05/27/2009 SUPPL-7 Labeling

Label is not available on this site.

09/20/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

LEUPROLIDE ACETATE

INJECTABLE;INJECTION; 1MG/0.2ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEUPROLIDE ACETATE LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE;INJECTION Prescription No AP 074728 SANDOZ
LEUPROLIDE ACETATE LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE;INJECTION Prescription No AP 078885 SUN PHARM
LEUPROLIDE ACETATE LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE;INJECTION Prescription No AP 075471 TEVA PHARMS USA

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