| 66715-6533-2 |
66715-6533 |
HUMAN OTC DRUG |
Advil PM, CVP HEALTH |
Ibuprofen and Diphenhydramine citrate |
TABLET, COATED |
ORAL |
20220506 |
N/A |
NDA |
NDA021394 |
Lil' Drug Store Products, Inc. |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
2 POUCH in 1 CARTON (66715-6533-2) / 2 TABLET, COATED in 1 POUCH |
| 66715-6433-2 |
66715-6433 |
HUMAN OTC DRUG |
Advil PM, TRAVEL BASIX |
Ibuprofen and Diphenhydramine citrate |
TABLET, COATED |
ORAL |
20221115 |
N/A |
NDA |
NDA021394 |
Lil' Drug Store Products, Inc. |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
2 POUCH in 1 CARTON (66715-6433-2) / 2 TABLET, COATED in 1 POUCH |
| 67751-147-01 |
67751-147 |
HUMAN OTC DRUG |
Advil PM |
DIPHENHYDRAMINE CITRATE, IBUPROFEN |
TABLET, COATED |
ORAL |
20160916 |
N/A |
NDA |
NDA021394 |
Navajo Manufacturing Company Inc. |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 POUCH in 1 CARTON (67751-147-01) / 2 TABLET, COATED in 1 POUCH |
| 67751-147-02 |
67751-147 |
HUMAN OTC DRUG |
Advil PM |
DIPHENHYDRAMINE CITRATE, IBUPROFEN |
TABLET, COATED |
ORAL |
20160916 |
N/A |
NDA |
NDA021394 |
Navajo Manufacturing Company Inc. |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
2 POUCH in 1 CARTON (67751-147-02) / 4 TABLET, COATED in 1 POUCH |
| 67751-147-06 |
67751-147 |
HUMAN OTC DRUG |
Advil PM |
DIPHENHYDRAMINE CITRATE, IBUPROFEN |
TABLET, COATED |
ORAL |
20250425 |
N/A |
NDA |
NDA021394 |
Navajo Manufacturing Company Inc. |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
3 POUCH in 1 CARTON (67751-147-06) / 2 TABLET, COATED in 1 POUCH |
| 0573-0164-04 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
4 TABLET, COATED in 1 POUCH (0573-0164-04) |
| 0573-0164-05 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE |
| 0573-0164-08 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20170317 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIAL |
| 0573-0164-09 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20170317 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
8 TABLET, COATED in 1 VIAL (0573-0164-09) |
| 0573-0164-12 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
6 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCH |
| 0573-0164-14 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
2 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCH |
| 0573-0164-20 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLE |
| 0573-0164-21 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLE |
| 0573-0164-30 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLE |
| 0573-0164-32 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLE |
| 0573-0164-33 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLE |
| 0573-0164-40 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLE |
| 0573-0164-41 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLE |
| 0573-0164-43 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLE |
| 0573-0164-44 |
0573-0164 |
HUMAN OTC DRUG |
ADVIL PM |
diphenhydramine citrate and ibuprofen |
TABLET, COATED |
ORAL |
20051221 |
N/A |
NDA |
NDA021394 |
Haleon US Holdings LLC |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
38 mg/1; 200 mg/1 |
1 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLE |