Product NDC: | 0121-4794 |
Proprietary Name: | Theophylline |
Non Proprietary Name: | THEOPHYLLINE ANHYDROUS |
Active Ingredient(s): | 80 mg/15mL & nbsp; THEOPHYLLINE ANHYDROUS |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0121-4794 |
Labeler Name: | Pharmaceutical Associates, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA085186 |
Marketing Category: | ANDA |
Start Marketing Date: | 20081103 |
Package NDC: | 0121-4794-15 |
Package Description: | 4 TRAY in 1 CASE (0121-4794-15) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE |
NDC Code | 0121-4794-15 |
Proprietary Name | Theophylline |
Package Description | 4 TRAY in 1 CASE (0121-4794-15) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE |
Product NDC | 0121-4794 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | THEOPHYLLINE ANHYDROUS |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 20081103 |
Marketing Category Name | ANDA |
Labeler Name | Pharmaceutical Associates, Inc. |
Substance Name | THEOPHYLLINE ANHYDROUS |
Strength Number | 80 |
Strength Unit | mg/15mL |
Pharmaceutical Classes | Methylxanthine [EPC],Xanthines [Chemical/Ingredient] |