Product NDC: | 54838-556 |
Proprietary Name: | Theophylline |
Non Proprietary Name: | Theophylline |
Active Ingredient(s): | 80 mg/15mL & nbsp; Theophylline |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54838-556 |
Labeler Name: | Silarx Pharmaceuticals, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091156 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110413 |
Package NDC: | 54838-556-80 |
Package Description: | 473 mL in 1 BOTTLE, PLASTIC (54838-556-80) |
NDC Code | 54838-556-80 |
Proprietary Name | Theophylline |
Package Description | 473 mL in 1 BOTTLE, PLASTIC (54838-556-80) |
Product NDC | 54838-556 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Theophylline |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 20110413 |
Marketing Category Name | ANDA |
Labeler Name | Silarx Pharmaceuticals, Inc |
Substance Name | THEOPHYLLINE ANHYDROUS |
Strength Number | 80 |
Strength Unit | mg/15mL |
Pharmaceutical Classes | Methylxanthine [EPC],Xanthines [Chemical/Ingredient] |