Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074728
Company: SANDOZ
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 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
08/04/1998 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74728ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74728.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2017 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

05/19/2017 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

11/17/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074728s011lbl.pdf
03/28/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

07/06/2008 SUPPL-7 Labeling

Label is not available on this site.

09/13/2006 SUPPL-6 Labeling

Label is not available on this site.

04/03/2001 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/18/1998 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/27/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074728s011lbl.pdf

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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