Details for New Drug Application (NDA): 205386
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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-one suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 205386
Tradename: | MORPHINE SULFATE |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | morphine sulfate |
Patents: | 0 |
Pharmacology for NDA: 205386
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 205386
Suppliers and Packaging for NDA: 205386
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 205386 | ANDA | Mayne Pharma Commercial LLC | 51862-185 | 51862-185-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-185-01) |
MORPHINE SULFATE | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 205386 | ANDA | Mayne Pharma Commercial LLC | 51862-186 | 51862-186-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-186-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Oct 28, 2016 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Oct 28, 2016 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Oct 28, 2016 | TE: | RLD: | No |
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