Details for New Drug Application (NDA): 203602
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The generic ingredient in MORPHINE SULFATE is morphine sulfate. There are twenty-three drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 203602
Tradename: | MORPHINE SULFATE |
Applicant: | Novel Labs Inc |
Ingredient: | morphine sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203602
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 203602
Suppliers and Packaging for NDA: 203602
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 203602 | ANDA | Novel Laboratories, Inc. | 40032-540 | 40032-540-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-540-01) |
MORPHINE SULFATE | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 203602 | ANDA | Novel Laboratories, Inc. | 40032-540 | 40032-540-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-540-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Dec 16, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Dec 16, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Dec 16, 2015 | TE: | AB | RLD: | No |
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