Details for New Drug Application (NDA): 207270
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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 207270
Tradename: | MORPHINE SULFATE |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | morphine sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207270
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 207270
Suppliers and Packaging for NDA: 207270
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | morphine sulfate | TABLET;ORAL | 207270 | ANDA | Mayne Pharma Commercial LLC | 51862-615 | 51862-615-01 | 100 TABLET in 1 BOTTLE (51862-615-01) |
MORPHINE SULFATE | morphine sulfate | TABLET;ORAL | 207270 | ANDA | Mayne Pharma Commercial LLC | 51862-617 | 51862-617-01 | 100 TABLET in 1 BOTTLE (51862-617-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Jan 12, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Jan 12, 2022 | TE: | RLD: | No |
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