Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078885
Company: SUN PHARM
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
03/09/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2017 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

05/19/2017 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

05/08/2015 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/26/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/28/2011 SUPPL-3 Labeling-Package Insert

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English