68791-101-01 |
68791-101 |
HUMAN PRESCRIPTION DRUG |
Derma-Smoothe/FS |
fluocinolone acetonide |
OIL |
TOPICAL |
20240506 |
N/A |
NDA |
NDA019452 |
Royal Pharmaceuticals |
FLUOCINOLONE ACETONIDE |
.11 mg/mL |
1 BOTTLE in 1 CARTON (68791-101-01) / 20 mL in 1 BOTTLE |
68791-101-04 |
68791-101 |
HUMAN PRESCRIPTION DRUG |
Derma-Smoothe/FS |
fluocinolone acetonide |
OIL |
TOPICAL |
19950216 |
N/A |
NDA |
NDA019452 |
Royal Pharmaceuticals |
FLUOCINOLONE ACETONIDE |
.11 mg/mL |
1 BOTTLE in 1 CARTON (68791-101-04) / 118.28 mL in 1 BOTTLE |
68791-102-01 |
68791-102 |
HUMAN PRESCRIPTION DRUG |
Derma-Smoothe/FS |
fluocinolone acetonide |
OIL |
TOPICAL |
20230817 |
N/A |
NDA |
NDA019452 |
Royal Pharmaceuticals |
FLUOCINOLONE ACETONIDE |
.11 mg/mL |
1 BOTTLE in 1 CARTON (68791-102-01) / 20 mL in 1 BOTTLE |
68791-102-04 |
68791-102 |
HUMAN PRESCRIPTION DRUG |
Derma-Smoothe/FS |
fluocinolone acetonide |
OIL |
TOPICAL |
19950216 |
N/A |
NDA |
NDA019452 |
Royal Pharmaceuticals |
FLUOCINOLONE ACETONIDE |
.11 mg/mL |
1 BOTTLE in 1 CARTON (68791-102-04) / 118.28 mL in 1 BOTTLE |
68791-103-20 |
68791-103 |
HUMAN PRESCRIPTION DRUG |
DermOtic |
fluocinolone acetonide |
OIL |
AURICULAR (OTIC) |
20051109 |
N/A |
NDA |
NDA019452 |
Royal Pharmaceuticals |
FLUOCINOLONE ACETONIDE |
.11 mg/mL |
1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) / 20 mL in 1 BOTTLE, DROPPER |
13925-508-20 |
13925-508 |
HUMAN PRESCRIPTION DRUG |
Fluocinolone acetonide 0.01% |
fluocinolone acetonide |
OIL |
AURICULAR (OTIC) |
20130801 |
N/A |
NDA AUTHORIZED GENERIC |
NDA019452 |
Seton Pharmaceuticals |
FLUOCINOLONE ACETONIDE |
.11 mg/mL |
1 BOTTLE, DROPPER in 1 CARTON (13925-508-20) / 20 mL in 1 BOTTLE, DROPPER |
13925-507-04 |
13925-507 |
HUMAN PRESCRIPTION DRUG |
Fluocinolone Acetonide |
fluocinolone acetonide |
OIL |
TOPICAL |
20130801 |
N/A |
NDA AUTHORIZED GENERIC |
NDA019452 |
Seton Pharmaceuticals |
FLUOCINOLONE ACETONIDE |
.11 mg/mL |
1 BOTTLE in 1 CARTON (13925-507-04) / 118.28 mL in 1 BOTTLE |