Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020515
Company: TERSERA

Products on NDA 020515

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020515

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/1995	ORIG-1	Approval	Type 6 - New Indication (no longer used)	STANDARD		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-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019726s076lbl020515s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/019726Orig1s076, 020515Orig1s013ltr.pdf
09/23/2025	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019726s074,020515s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/19726Orig1s074, 20515Orig1s011ltr.pdf

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