71858-0105-1 |
71858-0105 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
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) |
71858-0105-5 |
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 |
N/A |
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) |
71858-0115-5 |
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 |
N/A |
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) |
71858-0130-5 |
71858-0130 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
100 ug/mL |
6 POUCH in 1 CARTON (71858-0130-5) / 5 AMPULE in 1 POUCH (71858-0130-4) / 1 mL in 1 AMPULE (71858-0130-6) |
71858-0150-1 |
71858-0150 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
150 ug/mL |
2 POUCH in 1 CARTON (71858-0150-1) / 5 AMPULE in 1 POUCH (71858-0150-4) / 1 mL in 1 AMPULE (71858-0150-6) |
71858-0150-5 |
71858-0150 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
150 ug/mL |
6 POUCH in 1 CARTON (71858-0150-5) / 5 AMPULE in 1 POUCH (71858-0150-4) / 1 mL in 1 AMPULE (71858-0150-6) |
71858-0110-1 |
71858-0110 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
25 ug/mL |
2 POUCH in 1 CARTON (71858-0110-1) / 5 AMPULE in 1 POUCH (71858-0110-4) / 1 mL in 1 AMPULE (71858-0110-6) |
71858-0110-5 |
71858-0110 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
25 ug/mL |
6 POUCH in 1 CARTON (71858-0110-5) / 5 AMPULE in 1 POUCH (71858-0110-4) / 1 mL in 1 AMPULE (71858-0110-6) |
71858-0117-1 |
71858-0117 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20210701 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
62.5 ug/mL |
2 POUCH in 1 CARTON (71858-0117-1) / 5 AMPULE in 1 POUCH (71858-0117-4) / 1 mL in 1 AMPULE (71858-0117-6) |
71858-0117-5 |
71858-0117 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20210701 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
62.5 ug/mL |
6 POUCH in 1 CARTON (71858-0117-5) / 5 AMPULE in 1 POUCH (71858-0117-4) / 1 mL in 1 AMPULE (71858-0117-6) |
71858-0135-1 |
71858-0135 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
112 ug/mL |
2 POUCH in 1 CARTON (71858-0135-1) / 5 AMPULE in 1 POUCH (71858-0135-4) / 1 mL in 1 AMPULE (71858-0135-6) |
71858-0135-5 |
71858-0135 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
112 ug/mL |
6 POUCH in 1 CARTON (71858-0135-5) / 5 AMPULE in 1 POUCH (71858-0135-4) / 1 mL in 1 AMPULE (71858-0135-6) |
71858-0155-1 |
71858-0155 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
175 ug/mL |
2 POUCH in 1 CARTON (71858-0155-1) / 5 AMPULE in 1 POUCH (71858-0155-4) / 1 mL in 1 AMPULE (71858-0155-6) |
71858-0155-5 |
71858-0155 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
175 ug/mL |
6 POUCH in 1 CARTON (71858-0155-5) / 5 AMPULE in 1 POUCH (71858-0155-4) / 1 mL in 1 AMPULE (71858-0155-6) |
71858-0113-1 |
71858-0113 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20210701 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
44 ug/mL |
2 POUCH in 1 CARTON (71858-0113-1) / 5 AMPULE in 1 POUCH (71858-0113-4) / 1 mL in 1 AMPULE (71858-0113-6) |
71858-0113-5 |
71858-0113 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20210701 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
44 ug/mL |
6 POUCH in 1 CARTON (71858-0113-5) / 5 AMPULE in 1 POUCH (71858-0113-4) / 1 mL in 1 AMPULE (71858-0113-6) |
71858-0125-1 |
71858-0125 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
88 ug/mL |
2 POUCH in 1 CARTON (71858-0125-1) / 5 AMPULE in 1 POUCH (71858-0125-4) / 1 mL in 1 AMPULE (71858-0125-6) |
71858-0125-5 |
71858-0125 |
HUMAN PRESCRIPTION DRUG |
Tirosint SOL |
Levothyroxine Sodium |
SOLUTION |
ORAL |
20190301 |
N/A |
NDA |
NDA206977 |
IBSA Pharma Inc. |
LEVOTHYROXINE SODIUM |
88 ug/mL |
6 POUCH in 1 CARTON (71858-0125-5) / 5 AMPULE in 1 POUCH (71858-0125-4) / 1 mL in 1 AMPULE (71858-0125-6) |