 
                        | Product NDC: | 35356-837 | 
| Proprietary Name: | Morphine Sulfate | 
| Non Proprietary Name: | Morphine Sulfate | 
| Active Ingredient(s): | 200 mg/1 & nbsp; Morphine Sulfate | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 35356-837 | 
| Labeler Name: | Lake Erie Medical DBA Quality Care Products LLC | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA074769 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20110114 | 
| Package NDC: | 35356-837-30 | 
| Package Description: | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (35356-837-30) | 
| NDC Code | 35356-837-30 | 
| Proprietary Name | Morphine Sulfate | 
| Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (35356-837-30) | 
| Product NDC | 35356-837 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Morphine Sulfate | 
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE | 
| Route Name | ORAL | 
| Start Marketing Date | 20110114 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Lake Erie Medical DBA Quality Care Products LLC | 
| Substance Name | MORPHINE SULFATE | 
| Strength Number | 200 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |