| 71858-0112-1 |
71858-0112 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20210701 |
20260131 |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
37.5 ug/mL |
2 POUCH in 1 CARTON (71858-0112-1) / 5 AMPULE in 1 POUCH (71858-0112-4) / 1 mL in 1 AMPULE (71858-0112-6) |
| 71858-0112-2 |
71858-0112 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20250725 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
37.5 ug/mL |
6 POUCH in 1 CARTON (71858-0112-2) / 5 AMPULE in 1 POUCH (71858-0112-4) / 1 mL in 1 AMPULE (71858-0112-6) |
| 71858-0112-5 |
71858-0112 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20210701 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
37.5 ug/mL |
6 POUCH in 1 CARTON (71858-0112-5) / 5 AMPULE in 1 POUCH (71858-0112-4) / 1 mL in 1 AMPULE (71858-0112-6) |
| 71858-0120-1 |
71858-0120 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
20260131 |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
75 ug/mL |
2 POUCH in 1 CARTON (71858-0120-1) / 5 AMPULE in 1 POUCH (71858-0120-4) / 1 mL in 1 AMPULE (71858-0120-6) |
| 71858-0120-2 |
71858-0120 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20250725 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
75 ug/mL |
6 POUCH in 1 CARTON (71858-0120-2) / 5 AMPULE in 1 POUCH (71858-0120-4) / 1 mL in 1 AMPULE (71858-0120-6) |
| 71858-0120-5 |
71858-0120 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
75 ug/mL |
6 POUCH in 1 CARTON (71858-0120-5) / 5 AMPULE in 1 POUCH (71858-0120-4) / 1 mL in 1 AMPULE (71858-0120-6) |
| 71858-0140-1 |
71858-0140 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
20260131 |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
125 ug/mL |
2 POUCH in 1 CARTON (71858-0140-1) / 5 AMPULE in 1 POUCH (71858-0140-4) / 1 mL in 1 AMPULE (71858-0140-6) |
| 71858-0140-2 |
71858-0140 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20250725 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
125 ug/mL |
6 POUCH in 1 CARTON (71858-0140-2) / 5 AMPULE in 1 POUCH (71858-0140-4) / 1 mL in 1 AMPULE (71858-0140-6) |
| 71858-0140-5 |
71858-0140 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
125 ug/mL |
6 POUCH in 1 CARTON (71858-0140-5) / 5 AMPULE in 1 POUCH (71858-0140-4) / 1 mL in 1 AMPULE (71858-0140-6) |
| 71858-0160-1 |
71858-0160 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
20260131 |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
200 ug/mL |
2 POUCH in 1 CARTON (71858-0160-1) / 5 AMPULE in 1 POUCH (71858-0160-4) / 1 mL in 1 AMPULE (71858-0160-6) |
| 71858-0160-2 |
71858-0160 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20250725 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
200 ug/mL |
6 POUCH in 1 CARTON (71858-0160-2) / 5 AMPULE in 1 POUCH (71858-0160-4) / 1 mL in 1 AMPULE (71858-0160-6) |
| 71858-0160-5 |
71858-0160 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
200 ug/mL |
6 POUCH in 1 CARTON (71858-0160-5) / 5 AMPULE in 1 POUCH (71858-0160-4) / 1 mL in 1 AMPULE (71858-0160-6) |
| 71858-0105-1 |
71858-0105 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
20260131 |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
13 ug/mL |
2 POUCH in 1 CARTON (71858-0105-1) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) |
| 71858-0105-2 |
71858-0105 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20250725 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
13 ug/mL |
6 POUCH in 1 CARTON (71858-0105-2) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) |
| 71858-0105-5 |
71858-0105 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
13 ug/mL |
6 POUCH in 1 CARTON (71858-0105-5) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) |
| 71858-0115-1 |
71858-0115 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
20260131 |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
50 ug/mL |
2 POUCH in 1 CARTON (71858-0115-1) / 5 AMPULE in 1 POUCH (71858-0115-4) / 1 mL in 1 AMPULE (71858-0115-6) |
| 71858-0115-2 |
71858-0115 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20250725 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
50 ug/mL |
6 POUCH in 1 CARTON (71858-0115-2) / 5 AMPULE in 1 POUCH (71858-0115-4) / 1 mL in 1 AMPULE (71858-0115-6) |
| 71858-0115-5 |
71858-0115 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
50 ug/mL |
6 POUCH in 1 CARTON (71858-0115-5) / 5 AMPULE in 1 POUCH (71858-0115-4) / 1 mL in 1 AMPULE (71858-0115-6) |
| 71858-0130-1 |
71858-0130 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
20260131 |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
100 ug/mL |
2 POUCH in 1 CARTON (71858-0130-1) / 5 AMPULE in 1 POUCH (71858-0130-4) / 1 mL in 1 AMPULE (71858-0130-6) |
| 71858-0130-2 |
71858-0130 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20250725 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
100 ug/mL |
6 POUCH in 1 CARTON (71858-0130-2) / 5 AMPULE in 1 POUCH (71858-0130-4) / 1 mL in 1 AMPULE (71858-0130-6) |