Date |
Federal Register Citation |
Description |
4/5/1973 |
38FR8714 |
Advance Notice of Proposed Rulemaking |
5/29/1973 |
38FR14111 |
Correction: Advance Notice of Proposed Rulemaking |
11/12/1973 |
38FR31260
|
Tentative
Final Monograph |
12/7/1973 |
38FR33774
|
Correction: Tentative Final Monograph |
1/8/1974 |
39FR1359 |
Notice: Public hearing on Tentative Final Monograph |
1/22/1974 |
39FR2488 |
Proposed Rule:
Revised rate of acid addition |
2/21/1974 |
39FR6620 |
Correction: 1/22/1974 Proposed Rule |
6/4/1974 |
39FR19862
|
Final
Monograph |
6/20/1974 |
39FR22140
|
Correction: Final Monograph |
9/11/1974 |
39FR32736
|
Correction: Final Monograph |
11/8/1974 |
39FR39591 |
Notice: Withdraws NDA |
3/13/1975 |
40FR11718
|
Technical
Amendment: Revises indications |
5/23/1975 |
40FR22542
|
Technical
Amendment: Extends effective date |
5/23/1975 |
40FR22553
|
Proposed Rule: Revised in vitro test (temperature) |
10/15/1975 |
40FR48343 |
Final Rule: Revised in vitro test (temperature) |
12/15/1975 |
40FR58165
|
Notice:
Availability of Advisory Panel transcript |
9/5/1978 |
43FR39427
|
Notice: Classifies Category III active ingredients as
nonmonograph |
11/28/1978 |
43FR55464
|
Correction: 9/5/1978 Notice |
9/21/1979 |
44FR54731 |
Proposed Rule: Adds "upset stomach" indication |
10/19/1979 |
44FR60328
|
Proposed Rule:
Requires warning and directions (concomitant antibiotic use) for calcium & magnesium |
11/16/1979 |
44FR65992
|
Correction: 10/19/1979 Proposed Rule |
5/27/1980 |
45FR35349
|
Proposed Rule: Procedure for request in vitro test
modification |
8/31/1982 |
47FR38480 |
Final Rule: Procedure for request in vitro test
modification |
8/31/1982 |
47FR38481
|
Final Rule:
Adds "upset stomach" indication |
4/13/1984 |
49FR14908 |
Proposed Rule: Exempts from "accidental overdose"
warning |
5/21/1984 |
49FR21350
|
Correction: 4/13/1984 Proposed Rule |
7/30/1986 |
51FR27342
|
Proposed Rule: Requires prescription drug interaction
warning |
8/1/1986 |
51FR27763
|
Final Rule: Exempts from "accidental overdose"
warning |
9/5/1986 |
51FR31763 |
Correction: 8/1/1986 Final Rule |
9/10/1986 |
51FR32212 |
Correction: 8/1/1986 Final Rule |
10/1/1986 |
51FR35002
|
Extension of
comment period: 7/30/1986 Proposed Rule |
9/4/1987 |
52FR33576
|
Notice: Classifies alginic acid as nonmonograph |
11/16/1988 |
53FR46190
|
Proposed Rule: antacid and analgesic combinations |
12/24/1991 |
56FR66754
|
Proposed Rule: Adds overindulgence indication |
2/5/1992 |
57FR4456 |
Notice of Enforcement Policy: Allows marketing of antacid
and acetaminophen
combinations |
2/20/1992 |
57FR6165
|
Correction: 2/5/1992 Notice of Enforcement Policy |
2/28/1992 |
57FR6892
|
Correction: 2/5/1992 Notice of Enforcement Policy |
8/26/1993 |
58FR45204
|
Final Rule: Requires prescription drug interaction
warning |
9/23/1993 |
58FR49826 |
Proposed Rule: Requires in vitro test based on USP method |
2/2/1994 |
59FR5060
|
Proposed Rule:
Requires sodium bicarbonate (gastric rupture) warnings and
directions |
4/14/1994 |
59FR17747
|
Extension
of Comment Period: 2/2/1994 Proposed Rule |
11/25/1994 |
59FR60555
|
Correction:
8/26/1993 Final Rule |
2/8/1996 |
61FR4822
[HTML] |
Final Rule: Requires in vitro test based on USP method |
10/9/1997 |
62FR52659
[HTML] |
Correction: 2/8/1996 Proposed Rule |