Product NDC: | 16590-897 |
Proprietary Name: | EMBEDA |
Non Proprietary Name: | MORPHINE SUFATE |
Active Ingredient(s): | 20; .8 mg/1; mg/1 & nbsp; MORPHINE SUFATE |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16590-897 |
Labeler Name: | STAT RX USA LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022321 |
Marketing Category: | NDA |
Start Marketing Date: | 20090813 |
Package NDC: | 16590-897-30 |
Package Description: | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-897-30) |
NDC Code | 16590-897-30 |
Proprietary Name | EMBEDA |
Package Description | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-897-30) |
Product NDC | 16590-897 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | MORPHINE SUFATE |
Dosage Form Name | CAPSULE, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20090813 |
Marketing Category Name | NDA |
Labeler Name | STAT RX USA LLC |
Substance Name | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE |
Strength Number | 20; .8 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |