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2019-11-09
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Haemonetics Manufacturing, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Anticoagulant Citrate Dextrose Solution A, USP
Notices
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Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) BA 710497/0 for Anticoagulant Citrate Dextrose Solution A, USP (ACD-A), In Plastic Bags, held by Haemonetics Manufacturing, Inc. Haemonetics Manufacturing, Inc., requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.
84 FR 61065
https://www.govinfo.gov/app/details/FR-2019-11-12/2019-24527
2019-24527
fr12no19-76
4164-01-P
Docket No. FDA-2019-N-4777
https://www.govinfo.gov/app/details/FR-2019-11-12/2019-24527
https://www.govinfo.gov/content/pkg/FR-2019-11-12/html/2019-24527.htm
https://www.govinfo.gov/content/pkg/FR-2019-11-12/pdf/2019-24527.pdf
2 p.
61065
61066
84 FR 61065
Haemonetics Manufacturing, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Anticoagulant Citrate Dextrose Solution A, USP; Federal Register Vol. 84, Issue
NOTICE
2019-24527
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2019-N-4777
4164-01-P
2019-24527
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) BA 710497/0 for Anticoagulant Citrate Dextrose Solution A, USP (ACD-A), In Plastic Bags, held by Haemonetics Manufacturing, Inc. Haemonetics Manufacturing, Inc., requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.
Approval is withdrawn as of December 12, 2019.
Sana F. Hussain, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911.
Withdrawal of Approval of Abbreviated New Drug Application:
Anticoagulant Citrate Dextrose Solution A, USP; Haemonetics Manufacturing, Inc.
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Federal Register
Vol. 84, no. 218
Office of the Federal Register, National Archives and Records Administration
2019-11-12
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Table of Contents:
AE 2.7:
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https://www.govinfo.gov/app/details/FR-2019-11-12
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0097-6326
0042-1219
0364-1406
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000582072
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https://www.govinfo.gov/app/details/FR-2019-11-12
https://www.govinfo.gov/content/pkg/FR-2019-11-12/pdf/FR-2019-11-12.pdf
https://www.govinfo.gov/content/pkg/FR-2019-11-12/xml/FR-2019-11-12.xml
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