Details for New Drug Application (NDA): 022207
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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 022207
Tradename: | MORPHINE SULFATE |
Applicant: | Hikma |
Ingredient: | morphine sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022207
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 022207
Suppliers and Packaging for NDA: 022207
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | morphine sulfate | TABLET;ORAL | 022207 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-0235 | 0054-0235-24 | 100 BLISTER PACK in 1 CARTON (0054-0235-24) / 1 TABLET in 1 BLISTER PACK |
MORPHINE SULFATE | morphine sulfate | TABLET;ORAL | 022207 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-0235 | 0054-0235-25 | 100 TABLET in 1 BOTTLE (0054-0235-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Mar 17, 2008 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Jun 2, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Mar 17, 2008 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Jun 2, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION |
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