46287-020-01 |
46287-020 |
HUMAN PRESCRIPTION DRUG |
CaroSpir |
CaroSpir |
SUSPENSION |
ORAL |
20170804 |
N/A |
NDA |
NDA209478 |
CMP Pharma, Inc. |
SPIRONOLACTONE |
25 mg/5mL |
473 mL in 1 BOTTLE (46287-020-01) |
46287-020-04 |
46287-020 |
HUMAN PRESCRIPTION DRUG |
CaroSpir |
CaroSpir |
SUSPENSION |
ORAL |
20170804 |
N/A |
NDA |
NDA209478 |
CMP Pharma, Inc. |
SPIRONOLACTONE |
25 mg/5mL |
118 mL in 1 BOTTLE (46287-020-04) |
46287-020-50 |
46287-020 |
HUMAN PRESCRIPTION DRUG |
CaroSpir |
CaroSpir |
SUSPENSION |
ORAL |
20210715 |
N/A |
NDA |
NDA209478 |
CMP Pharma, Inc. |
SPIRONOLACTONE |
25 mg/5mL |
10 CUP, UNIT-DOSE in 1 CARTON (46287-020-50) / 5 mL in 1 CUP, UNIT-DOSE |
17856-0120-1 |
17856-0120 |
HUMAN PRESCRIPTION DRUG |
CaroSpir |
CaroSpir |
SUSPENSION |
ORAL |
20240412 |
N/A |
NDA |
NDA209478 |
ATLANTIC BIOLOGICALS CORP. |
SPIRONOLACTONE |
25 mg/5mL |
72 CUP in 1 BOX (17856-0120-1) / 2.5 mL in 1 CUP (17856-0120-2) |
17856-1133-1 |
17856-1133 |
HUMAN PRESCRIPTION DRUG |
SPIRONOLACTONE |
spironolactone |
SUSPENSION |
ORAL |
20240603 |
N/A |
NDA AUTHORIZED GENERIC |
NDA209478 |
ATLANTIC BIOLOGICALS CORP. |
SPIRONOLACTONE |
25 mg/5mL |
1 SYRINGE in 1 BAG (17856-1133-1) / 2.5 mL in 1 SYRINGE |
0574-1133-04 |
0574-1133 |
HUMAN PRESCRIPTION DRUG |
SPIRONOLACTONE |
spironolactone |
SUSPENSION |
ORAL |
20231031 |
N/A |
NDA AUTHORIZED GENERIC |
NDA209478 |
Padagis US LLC |
SPIRONOLACTONE |
25 mg/5mL |
118 mL in 1 BOTTLE (0574-1133-04) |
0574-1133-10 |
0574-1133 |
HUMAN PRESCRIPTION DRUG |
SPIRONOLACTONE |
spironolactone |
SUSPENSION |
ORAL |
20231031 |
N/A |
NDA AUTHORIZED GENERIC |
NDA209478 |
Padagis US LLC |
SPIRONOLACTONE |
25 mg/5mL |
10 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05) |
0574-1133-16 |
0574-1133 |
HUMAN PRESCRIPTION DRUG |
SPIRONOLACTONE |
spironolactone |
SUSPENSION |
ORAL |
20231031 |
N/A |
NDA AUTHORIZED GENERIC |
NDA209478 |
Padagis US LLC |
SPIRONOLACTONE |
25 mg/5mL |
473 mL in 1 BOTTLE (0574-1133-16) |