Product NDC: | 0378-2658 |
Proprietary Name: | Morphine Sulfate |
Non Proprietary Name: | morphine sulfate |
Active Ingredient(s): | 15 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: | 0378-2658 |
Labeler Name: | Mylan Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA200824 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130319 |
Package NDC: | 0378-2658-05 |
Package Description: | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2658-05) |
NDC Code | 0378-2658-05 |
Proprietary Name | Morphine Sulfate |
Package Description | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2658-05) |
Product NDC | 0378-2658 |
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 | 20130319 |
Marketing Category Name | ANDA |
Labeler Name | Mylan Pharmaceuticals Inc. |
Substance Name | MORPHINE SULFATE |
Strength Number | 15 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |