FDF
No. | Therapy Area | FDF | Strengh | CTD | Exp. (mths) | Stability Condition |
1 |
Dermatological 皮肤 |
Tacrolimus Ointment 他克莫司软膏 |
0.1% (10g/10mg); 0.03% (10g/3mg) |
IHS |
36 |
L: 25±2℃, RH60±5%; A: 30±2℃, RH65±5% |
2 |
Minoxidil Topical Solution 米诺地尔外用溶液 |
5% (60ml/3.0g); 2% (60ml/1.2g) |
IHS |
36 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
|
3 |
Weight Reduction 减肥 |
Orlistat Capsules 奥利司他胶囊 |
120mg |
IHS |
36 |
L: 25±2℃, RH60±5%; A: 30±2℃, RH65±5% |
4 |
Anti-depressant 抗抑郁 |
Vortioxetine Hydrobromide Tablets 氢溴酸伏硫西汀片 |
10mg |
IHS |
36 |
L: 30±2℃, RH65±5%; A: 40±2℃, RH75±5% |
5 |
Anti-influenza 抗流感 |
Oseltamivir Phosphate Capsules 磷酸奥司他韦胶囊 |
75mg 45mg 30mg |
IHS |
48 ; 36 ; 36 |
L: 30±2℃, RH65±5%; A: 40±2℃, RH75±5% |
6 |
Cardiovascular 心血管 |
Nitroglycerin Injection 硝酸甘油注射液 |
10ml/50mg |
IHS |
24 |
L: 25±2℃, RH60±5%; A: 40±2℃, RH75±5% |
7 |
Bumetanide Injection 布美他尼注射液 |
4ml/1mg |
IHS |
24 |
L: 25±2℃, RH60±5%; A: 40±2℃, RH75±5% |
|
8 |
Ophthalmic 眼科 |
Diquafosol Sodium Eye Drops 地夸磷索钠滴眼液 |
3% (5ml/150mg) |
IHS |
36 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
9 |
Bromfenac Sodium Eye Drops 溴芬酸钠滴眼液
|
0.1% (5ml/5mg) |
IHS |
24 |
L: 25±2℃, RH40±5%; A: 40±2℃, RH below25% |
|
10 |
0.1% (0.4ml/0.4mg) Preservative-Free 无防腐剂 |
IHS |
24 |
L: 25±2℃, RH40±5%; A: 40±2℃, RH below25% |
||
11 |
Sodium Hyaluronate Eye Drops 玻璃酸钠滴眼液 |
0.3% (5ml/15mg) | IHS | 36 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
|
12 |
0.3% (0.4ml/1.2mg) Preservative-Free 无防腐剂 |
IHS | 36 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
||
13 |
0.1% (10ml/10mg) Preservative-Free 无防腐剂 |
IHS | 24 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
||
14 | 0.1% (10ml/10mg) | IHS | 36 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
||
15 |
0.1% (0.4ml/0.4mg) Preservative-Free 无防腐剂 |
IHS | 24 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
||
16 |
Pranoprofen Eye Drops 普拉洛芬滴眼液 |
0.1% (5ml/5mg) | IHS | 24 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
|
17 |
Moxifloxacin Ophthalmic Solution 盐酸莫西沙星滴眼液 |
0.5% (5ml/25mg) | IHS | 24 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
|
18 |
Travoprost Ophthalmic Solution 曲伏前列素滴眼液 |
0.004% (2.5ml/0.1mg) | IHS | 24 |
L: 25±2℃, RH40±5%; A: 40±2℃, RH below25% |
|
19 |
Levofloxacin Eye Drops 左氧氟沙星滴眼液 |
0.488(0.4ml/1.952mg) Preservative-Free 无防腐剂 |
IHS | 36 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
|
20 | 0.488% (5ml/24.4mg) | IHS | 36 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
||
21 |
Polyvinyl Alcohol Eye Drops 聚乙烯醇滴眼液 |
10ml/0.14g Preservative-Free 无防腐剂 |
IHS | 24 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
|
22 | 10ml/0.14g | IHS | 24 |
L: 30±2℃, RH35±5%; A: 40±2℃, RH below25% |
||
23 |
Anti-influenza 抗流感 |
Oseltamivir Phosphate For Oral Suspension 磷酸奥司他韦干混悬剂 |
0.36g | IHS | 24 |
L: 25±2℃, RH60±5%; A: 40±2℃, RH75±5% |
24 |
Cardiovascular 心血管 |
Epalrestat Tablets 依帕司他片 |
50mg | IHS | 24 |
L: 25±2℃, RH60±5%; A: 40±2℃, RH75±5% |
25 |
Hair dyed black 黑发染发 |
Hair Curing Cream 养发膏 |
30g/tube | IHS | 36 | / |