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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 050114
Company: ALLERQUEST

Products on BLA 050114

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRE-PEN	BENZYLPENICILLOYL POLYLYSINE	60UMOLAR	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 050114

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/1974	ORIG-1	Approval		N/A		This Former NDA Was Deemed To Be a BLA on March 23, 2020. Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2023	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050114s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050114Orig1s010ltr.pdf
09/18/2009	SUPPL-8	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050114s008ltr.pdf
04/06/2000	SUPPL-7	Supplement		Label is not available on this site.
03/30/1989	SUPPL-5	Supplement		Label is not available on this site.
12/02/1981	SUPPL-4	Supplement		Label is not available on this site.
11/28/1978	SUPPL-3	Supplement		Label is not available on this site.
02/09/1976	SUPPL-2	Supplement		Label is not available on this site.
10/30/1974	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 050114

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2023	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050114s010lbl.pdf
01/18/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050114s010lbl.pdf

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