Details for New Drug Application (NDA): 210610
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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 210610
Tradename: | MORPHINE SULFATE |
Applicant: | Upsher Smith Labs |
Ingredient: | morphine sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210610
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 210610
Suppliers and Packaging for NDA: 210610
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | morphine sulfate | TABLET;ORAL | 210610 | ANDA | Upsher-Smith Laboratories, LLC | 0832-0273 | 0832-0273-11 | 100 TABLET in 1 BOTTLE (0832-0273-11) |
MORPHINE SULFATE | morphine sulfate | TABLET;ORAL | 210610 | ANDA | Upsher-Smith Laboratories, LLC | 0832-0274 | 0832-0274-11 | 100 TABLET in 1 BOTTLE (0832-0274-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Jul 22, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Jul 22, 2019 | TE: | AB | RLD: | No |
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