| Specifications | Department of Health and Human Services\r\nFood and Drug Administration\r\nCenter for Biologics Evalu\ ation and Research FDA-2567 |
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| Specifications | Department of Health and Human Services\r\nFood and Drug Administration\r\nCenter for Biologics Evalu\ ation and Research FDA-2567 |
| Business section |
| Specifications | Department of Health and Human Services\r\nFood and Drug Administration\r\nCenter for Biologics Evalu\ ation and Research FDA-2567 |
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| Content | NOTE:No license may be granted unless this completed submittal form has been received (U.S. Public Health Service Act, Section 351; the Federal Food, Drug, and Cosmetic Act, Section 502; and Title 21 U.S. Code of Federal Regulations, Part 600). PRODUCT NAME 6. 11. COMMENTS(Include any Manuf. ID number, description or revision no. of label being replaced. IF FINAL PRINTED, provide LOT NO. & DATE of FIRST USE.) TRANSMITTAL OF LABELS AND CIRCULARS 1.LABEL REVIEW NO. AND REVISIONDEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH MANUFAC- TURER NAME AND RETURN ADDRESS LABELING DETAILS 10. CHECK BOX IF THIS LABELING IS IN SUPPORT OF:Part of an Annual Report Associated BLA /PLA No. COMMENTS(See attached comments) Form Approved; OMB No. 0910-0338. Expiration Date: December 31, 2013 See OMB statement on reverse. SIGNATURE Draft 7. Final(in distribution) 4. LICENSE NO. 2. CHECK ONE 9.CHECK THE BOX(es) INDICATING FORMAT OF THIS SUBMISSION(More than one may be checked.) 3. LABEL TYPE CODES (select only one) REVIEW & REVISION NO.DATE REPLACES PREVIOUS LABELLABEL TYPE CODE (see below) CIRCCircular CONTContainer PACKPackage PCKRPacker SHIPShipping BULKBulk OTHROther(Specify in Comments) DILTDiluent BLSTBlister CRTNCarton 8. SUBMISSION REASONS(Check all that apply) AUTHORIZED OFFICIAL 12. 5. REGISTRATION NO. Electronic RETURNED BY REVIEWED BY DATE PREVIOUS EDITION IS OBSOLETE. SIGNATURE DATESIGNATURE FORM FDA 2567 (1/11)FRONT Paper Application DATE Supplement Manufacturing Method Change Anticoagulant / Additive Change Contraindications, Adverse Reactions, Precautions Other(Specify in Comments) New Scientific Information Editorial, Format New Formulation Dosage Change New Product New Indication THE SPACES BELOW ARE FOR USE BY CENTER FOR BIOLOGICS EVALUATION AND RESEARCH PSC Publishing Services (301) 443-6740 EF |
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| Following Datasheets | UCM082725-1_1 (1 pages) UCM082725_1 (1 pages) UCM083533_1 (2 pages) UCM083558_1 (2 pages) UCM083570_1 (1 pages) ucm085819_1 (3 pages) UCM086233_1 (46 pages) ucm089021_1 (4 pages) ucm089809_1 (6 pages) ucm089823_1 (3 pages) |
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