An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074728
Company: SANDOZ

Products on ANDA 074728

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074728

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/06/2026	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
04/30/2026	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
09/23/2025	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
02/01/2021	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
02/01/2021	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
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.

Labels for ANDA 074728

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

Therapeutic Equivalents for ANDA 074728

LEUPROLIDE ACETATE

SOLUTION;SUBCUTANEOUS; 14MG/2.8ML (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	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	215336	AMNEAL
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	212963	EUGIA PHARMA
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	075471	MEITHEAL
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	074728	SANDOZ
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	213829	SOMERSET THERAPS LLC
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	078885	SUN PHARM
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	217957	UBI
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	215826	ZYDUS PHARMS

Top