| Product NDC: | 42549-538 |
| Proprietary Name: | KETOTOLAC TROMETHAMINE |
| Non Proprietary Name: | KETOTOLAC TROMETHAMINE |
| Active Ingredient(s): | 10 mg/1 & nbsp; KETOTOLAC TROMETHAMINE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 42549-538 |
| Labeler Name: | STAT Rx USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA074761 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20100915 |
| Package NDC: | 42549-538-12 |
| Package Description: | 12 TABLET, FILM COATED in 1 BOTTLE (42549-538-12) |
| NDC Code | 42549-538-12 |
| Proprietary Name | KETOTOLAC TROMETHAMINE |
| Package Description | 12 TABLET, FILM COATED in 1 BOTTLE (42549-538-12) |
| Product NDC | 42549-538 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | KETOTOLAC TROMETHAMINE |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20100915 |
| Marketing Category Name | ANDA |
| Labeler Name | STAT Rx USA LLC |
| Substance Name | KETOROLAC TROMETHAMINE |
| Strength Number | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |