| 70000-0734-1 |
70000-0734 |
HUMAN OTC DRUG |
8HR Muscle Aches and Pain Relief |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20250615 |
N/A |
ANDA |
ANDA215486 |
LEADER/ Cardinal Health 110, Inc. |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (70000-0734-1) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 49483-704-05 |
49483-704 |
HUMAN OTC DRUG |
Muscle Aches and Pains Acetaminophen extended release |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20221107 |
N/A |
ANDA |
ANDA215486 |
TIME CAP LABORATORIES, INC. |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (49483-704-05) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 51316-354-42 |
51316-354 |
HUMAN OTC DRUG |
8 HR MUSCLE ACHES AND PAIN |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20250625 |
N/A |
ANDA |
ANDA215486 |
CVS Pharmacy |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (51316-354-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 25000-108-02 |
25000-108 |
HUMAN OTC DRUG |
Acetaminophen Extended-Release Tablets, 650 mg |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20221014 |
N/A |
ANDA |
ANDA215486 |
MARKSANS PHARMA LIMITED |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (25000-108-02) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 25000-108-08 |
25000-108 |
HUMAN OTC DRUG |
Acetaminophen Extended-Release Tablets, 650 mg |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20221014 |
N/A |
ANDA |
ANDA215486 |
MARKSANS PHARMA LIMITED |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (25000-108-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 76420-914-01 |
76420-914 |
HUMAN OTC DRUG |
Acetaminophen |
Acetaminophen tablet extended release |
TABLET, EXTENDED RELEASE |
ORAL |
20250127 |
N/A |
ANDA |
ANDA215486 |
Asclemed USA, Inc. |
ACETAMINOPHEN |
650 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-01) |
| 76420-914-05 |
76420-914 |
HUMAN OTC DRUG |
Acetaminophen |
Acetaminophen tablet extended release |
TABLET, EXTENDED RELEASE |
ORAL |
20250127 |
N/A |
ANDA |
ANDA215486 |
Asclemed USA, Inc. |
ACETAMINOPHEN |
650 mg/1 |
50 BOTTLE in 1 CARTON (76420-914-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 76420-914-26 |
76420-914 |
HUMAN OTC DRUG |
Acetaminophen |
Acetaminophen tablet extended release |
TABLET, EXTENDED RELEASE |
ORAL |
20250125 |
N/A |
ANDA |
ANDA215486 |
Asclemed USA, Inc. |
ACETAMINOPHEN |
650 mg/1 |
225 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-26) |
| 76420-914-40 |
76420-914 |
HUMAN OTC DRUG |
Acetaminophen |
Acetaminophen tablet extended release |
TABLET, EXTENDED RELEASE |
ORAL |
20250127 |
N/A |
ANDA |
ANDA215486 |
Asclemed USA, Inc. |
ACETAMINOPHEN |
650 mg/1 |
400 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-40) |
| 76420-914-42 |
76420-914 |
HUMAN OTC DRUG |
Acetaminophen |
Acetaminophen tablet extended release |
TABLET, EXTENDED RELEASE |
ORAL |
20250127 |
N/A |
ANDA |
ANDA215486 |
Asclemed USA, Inc. |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (76420-914-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 76420-914-60 |
76420-914 |
HUMAN OTC DRUG |
Acetaminophen |
Acetaminophen tablet extended release |
TABLET, EXTENDED RELEASE |
ORAL |
20250225 |
N/A |
ANDA |
ANDA215486 |
Asclemed USA, Inc. |
ACETAMINOPHEN |
650 mg/1 |
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-60) |
| 0363-9781-01 |
0363-9781 |
HUMAN OTC DRUG |
Arthritis Pain Reliever |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20220928 |
N/A |
ANDA |
ANDA215486 |
WALGREENS |
ACETAMINOPHEN |
650 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0363-9781-01) |
| 0363-9781-42 |
0363-9781 |
HUMAN OTC DRUG |
Arthritis Pain Reliever |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20221122 |
N/A |
ANDA |
ANDA215486 |
WALGREENS |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (0363-9781-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 55910-892-05 |
55910-892 |
HUMAN OTC DRUG |
8 hr Arthritis Pain Relief |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20230429 |
N/A |
ANDA |
ANDA215486 |
DOLGENCORP, INC. |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (55910-892-05) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 55910-892-26 |
55910-892 |
HUMAN OTC DRUG |
8 hr Arthritis Pain Relief |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20230429 |
N/A |
ANDA |
ANDA215486 |
DOLGENCORP, INC. |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (55910-892-26) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 55910-892-42 |
55910-892 |
HUMAN OTC DRUG |
8 hr Arthritis Pain Relief |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20230429 |
N/A |
ANDA |
ANDA215486 |
DOLGENCORP, INC. |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (55910-892-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 21130-097-01 |
21130-097 |
HUMAN OTC DRUG |
Arthritis Pain |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20230613 |
N/A |
ANDA |
ANDA215486 |
BETTER LIVING BRANDS, LLC |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (21130-097-01) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 21130-097-05 |
21130-097 |
HUMAN OTC DRUG |
Arthritis Pain |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20230613 |
N/A |
ANDA |
ANDA215486 |
BETTER LIVING BRANDS, LLC |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (21130-097-05) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 51316-969-01 |
51316-969 |
HUMAN OTC DRUG |
8HR Arthritis Pain Relief |
Acetaminophen 650mg |
TABLET, EXTENDED RELEASE |
ORAL |
20250701 |
N/A |
ANDA |
ANDA215486 |
CVS Pharmacy |
ACETAMINOPHEN |
650 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51316-969-01) |
| 70000-0733-1 |
70000-0733 |
HUMAN OTC DRUG |
8HR Arthritis Pain Relief |
Acetaminophen |
TABLET, EXTENDED RELEASE |
ORAL |
20250615 |
N/A |
ANDA |
ANDA215486 |
LEADER/ Cardinal Health 110, Inc. |
ACETAMINOPHEN |
650 mg/1 |
1 BOTTLE in 1 CARTON (70000-0733-1) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE |