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Rulemaking History for OTC Antiemetic Drug Products
View by Topic
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Final Monograph (21 CFR part 336):
Antiemetic Drug Products for Over-the-Counter Human Use
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| Date |
Federal Register Citation |
Description |
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3/21/1975 |
40FR12902  |
Advance Notice of Proposed
Rulemaking |
|
7/13/1979 |
44FR41064 |
Tentative Final Monograph |
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10/26/1979 |
44FR61610 |
Reopening of Administrative Record: Category II
and III active ingredients |
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4/30/1987 |
52FR15886 |
Final Monograph |
|
9/15/1988 |
53FR35808 |
Technical Amendment: Clarifies age range for
children's dosage |
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8/26/1993 |
58FR45216 |
Proposed Rule: Warnings related to age |
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4/11/1994 |
59FR16981 |
Final Rule: Warnings related to age |
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8/29/1997 |
62FR45767
[HTML] |
Proposed Rule: Requires warnings for
diphenhydramine |
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12/6/2002 |
67FR72555
[HTML] |
Final Rule: Requires warnings for
diphenhydramine |
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Date updated: May 8, 2007 |
