| Specifications | Issued February 7, 2012 Currently Approved CBER NDAs/ANDAs - updated 1/31/12 Currently Approved CBER NDAs/ANDAs CBER |
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| Specifications | Issued February 7, 2012 Currently Approved CBER NDAs/ANDAs - updated 1/31/12 Currently Approved CBER NDAs/ANDAs CBER |
| Business section |
| Specifications | Issued February 7, 2012 Currently Approved CBER NDAs/ANDAs - updated 1/31/12 Currently Approved CBER NDAs/ANDAs CBER |
| Suggested Link Details/Purchase | |
| Content | Currently Approved CBER NDAs/ANDAs As of February 01, 2012 Sorted by Applicant Name BN860909 Alpha Therapeutic Corporation 5555 Valley Boulevard Los Angeles, CA 90032 Product Name: Perfluorochemical Emulsion Trade Name: Approved Date: 26-DEC-1989 BN090024 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Dextran 70 Trade Name: Approved Date: 18-AUG-1969 BN160767 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Dextran 40 Trade Name: Approved Date: 06-APR-1970 BN160889 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Hetastarch Trade Name: HESPAN 6% Hetastarch in 0.9% NaCl in Glass Bottles Approved Date: 17-JUL-1972 BN841207 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Pentastarch Trade Name: PENTASPAN 10% Pentastarch in 0.9% NaCl in 500mL Glass Bottl Approved Date: 19-MAY-1987 BN890104 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Pentastarch Trade Name: PENTASPAN (R) 10% Pentastarch in 0.9% NaCl in EXCEL Containers Approved Date: 04-APR-1991 Approved Under McGaw, Inc BN890105 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Hetastarch Trade Name: HESPAN (R) 6% Hetastarch in 0.9% NaCl, 250, 500, 1000 ml EXCEL Containers |
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| Following Datasheets | UCM149975_1 (125 pages) UCM152828_1 (6 pages) UCM163159_1 (1 pages) UCM163919_1 (1 pages) UCM171764_1 (5 pages) UCM173430 (2 pages) UCM188476_1 (4 pages) UCM189544 (7 pages) UCM190609_1 (15 pages) UCM191474_1 (99 pages) |
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