Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Biologic License Application (BLA): 103575
Company: CENTOCOR INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REOPRO ABCIXIMAB 2MG/ML INJECTABLE; INJECTION Prescription None No No
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English