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mayur661 ☆ India, 2018-11-13 10:33 (1988 d 20:16 ago) Posting: # 19592 Views: 1,830 |
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There are some Oral Solution drug product having AB rating as per Orange book. But for these product there is no OGD recommendation is listed. Whether for this product bio-equivalence study need to be required in ANDA submission. |
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Ohlbe ★★★ France, 2018-11-13 11:19 (1988 d 19:30 ago) @ mayur661 Posting: # 19593 Views: 1,545 |
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Dear Mayur, You have already been reminded in the past of the forum policy. Not following it significantly decreases your chances of getting an answer, and may result in your account getting blocked temporarily or permanently. — Regards Ohlbe |
Ing. Helmut Schütz