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

Biologic License Application (BLA): 103362
Company: BERLEX LABS

Products on BLA 103362

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUKINE	SARGRAMOSTIM	250UG/ML	VIAL	Prescription	None	No	No
LEUKINE	SARGRAMOSTIM	500UG/ML	VIAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103362

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/1991	ORIG-1	Approval		N/A; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/05/2022	SUPPL-5249	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103362s5249lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103362Orig1s5249ltr.pdf
03/29/2018	SUPPL-5240	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5240lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103362Orig1s5240ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/103362Orig1s5240.pdf
02/10/2017	SUPPL-5237	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103362s5237lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103362Orig1s5237ltr.pdf
11/04/2008	SUPPL-5140	Supplement		Label is not available on this site.
03/14/2002	SUPPL-5012	Supplement		Label is not available on this site.
11/24/1995	SUPPL-1048	Supplement		Label is not available on this site.
12/22/1995	SUPPL-1045	Supplement		Label is not available on this site.
09/15/1995	SUPPL-1033	Supplement		Label is not available on this site.

Labels for BLA 103362

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/05/2022	SUPPL-5249	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103362s5249lbl.pdf
03/29/2018	SUPPL-5240	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5240lbl.pdf
02/10/2017	SUPPL-5237	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103362s5237lbl.pdf

Top