| Applicant Company |
Sandoz Philippines Corporation
|
| Brand Name |
1St: Azyth D
2Nd: Azyth 2H
|
| Generic Name |
Azithromycin Dihydrate
|
| Dosage Strength |
200 mg per 5 mL
|
| Dosage Form |
Powder For Suspension
|
| Packaging |
30 mL HDPE Bottle with Plastic Oral Syringe (10 mL) (Box of 1’s) Net: 15 mL;
30 mL HDPE Bottle with Plastic Oral Syringe (10 mL) (Box of 1’s) Net: 22.5 mL;
60 mL HDPE Bottle with Plastic Oral Syringe (10 mL) (Box of 1’s) Net: 30 mL;
60 mL HDPE Bottle with Plastic Oral Syringe (10 mL) (Box of 1’s) Net: 37.5 mL
|
| Pharmacologic Category |
Antibacterial (Macrolide)
|
| Application Type |
Initial
|