Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020515
Company: TERSERA

Products on NDA 20515

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLADEX	GOSERELIN	3.6MG	IMPLANT;IMPLANTATION	Prescription	None	No	No

Labels for NDA 020515

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/06/2026	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019726s076lbl020515s013lbl.pdf
09/23/2025	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019726s074,020515s011lbl.pdf