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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103575
Company: CENTOCOR INC

Products on BLA 103575

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REOPRO	ABCIXIMAB	2MG/ML	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103575

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1994	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
08/07/2019	SUPPL-5318	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103575s5318lbl.pdf
08/07/2019	SUPPL-5138	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103575s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103575Orig1s5138ltr.pdf
11/25/2013	SUPPL-5126	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103575s5126lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103575Orig1s5126ltr.pdf
11/21/2003	SUPPL-5025	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103575-5025ltr.pdf
11/21/2003	SUPPL-5022	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103575-5022ltr.pdf
01/23/2001	SUPPL-1015	Supplement		Label is not available on this site.
11/05/1997	SUPPL-1010	Supplement	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/abcicen110597-lab.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/abcicen110597-ltr.pdf https://web.archive.org/web/20170113111532/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093336.htm
11/05/1997	SUPPL-1008	Supplement	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/abcicen110597-lab.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/abcicen110597-ltr.pdf https://web.archive.org/web/20170113111532/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093336.htm

Labels for BLA 103575

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/07/2019	SUPPL-5318	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103575s5318lbl.pdf
08/07/2019	SUPPL-5138	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103575s5138lbl.pdf
11/25/2013	SUPPL-5126	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103575s5126lbl.pdf
11/05/1997	SUPPL-1010	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/abcicen110597-lab.pdf
11/05/1997	SUPPL-1008	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/abcicen110597-lab.pdf

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