Details for New Drug Application (NDA): 202348
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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 202348
Tradename: | MORPHINE SULFATE |
Applicant: | Specgx Llc |
Ingredient: | morphine sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202348
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 202348
Suppliers and Packaging for NDA: 202348
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | morphine sulfate | SOLUTION;ORAL | 202348 | ANDA | SpecGx LLC | 0406-8003 | 0406-8003-12 | 6 CARTON in 1 CASE (0406-8003-12) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC |
MORPHINE SULFATE | morphine sulfate | SOLUTION;ORAL | 202348 | ANDA | SpecGx LLC | 0406-8003 | 0406-8003-15 | 6 CARTON in 1 CASE (0406-8003-15) / 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Jul 15, 2011 | TE: | AA | RLD: | No |
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