Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761184
Company: PFIZER IRELAND PHARMACEUTICALS

Products on BLA 761184

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NGENLA	SOMATROGON-GHLA	24MG	INJECTABLE;INJECTION	Prescription	None	No	No
NGENLA	SOMATROGON-GHLA	60MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761184

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2023	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761184Orig1s000Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761184Orig1s000Corrected_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761184Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2025	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761184s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761184Orig1s006ltr.pdf
07/05/2024	SUPPL-3	Supplement		Label is not available on this site.
12/27/2023	SUPPL-1	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761184Orig1s001ltr.pdf

Labels for BLA 761184

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2025	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761184s006lbl.pdf
06/27/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761184Orig1s000Corrected_lbl.pdf