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NDA 12 731 held by Merck Co. Inc. Merck. a synthetic adrenocortical steroid was initially approved on March 29 1961 solely on the basis of safety. 04 and 0. 01 future applicants are advised that they may not be able to obtain 0. 04 or AEROSEB-DEX 0. ANDAs that refer to 0. 01 may be approved by the Agency as long as they meet all other legal and ANDAs. The Food and Drug that Topical Aerosol 0. 04 and AEROSEBDEX Topical Aerosol 0. 01 was withdrawn from sale for Although the citizen petition did...
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