Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 017776
Company: JUBILANT DRAXIMAGE

• This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 017776

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PULMOLITE	TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT	N/A	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 017776

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/1976	ORIG-1	Approval		N/A		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2002	SUPPL-19	Supplement		Label is not available on this site.
05/24/2001	SUPPL-18	Supplement		Label is not available on this site.
06/15/2000	SUPPL-16	Supplement		Label is not available on this site.
02/07/2000	SUPPL-15	Supplement		Label is not available on this site.
07/13/1999	SUPPL-14	Supplement		Label is not available on this site.
03/24/1998	SUPPL-13	Supplement		Label is not available on this site.
10/01/1997	SUPPL-12	Supplement		Label is not available on this site.
01/25/1995	SUPPL-11	Supplement		Label is not available on this site.
05/02/1989	SUPPL-10	Supplement		Label is not available on this site.
05/19/1989	SUPPL-9	Supplement		Label is not available on this site.
05/03/1985	SUPPL-8	Supplement		Label is not available on this site.
07/31/1992	SUPPL-7	Supplement		Label is not available on this site.
05/31/1983	SUPPL-6	Supplement		Label is not available on this site.
10/22/1985	SUPPL-5	Supplement		Label is not available on this site.
07/24/1980	SUPPL-4	Supplement		Label is not available on this site.