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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078885
Company: SUN PHARM

Products on ANDA 078885

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078885

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
05/06/2026	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
09/23/2025	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
09/19/2025	SUPPL-32	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/20/2020	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
11/20/2020	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
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-Package Insert, Labeling-Medication Guide		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.

Therapeutic Equivalents for ANDA 078885

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

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