Details for New Drug Application (NDA): 022195
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NDA 022195 describes MORPHINE SULFATE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Nortec Dev Assoc, Strides Pharma, Teva Pharms Usa, Upsher Smith Labs, Hikma, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms, Chartwell Molecular, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Dava Pharms Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Alkem Labs Ltd, Ingenus Pharms Nj, and Meridian Medcl Techn, and is included in sixty-two NDAs. It is available from twenty-nine suppliers. There are three patents protecting this drug. Additional details are available on the MORPHINE SULFATE profile page.
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.
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 022195
| Tradename: | MORPHINE SULFATE |
| Applicant: | Hikma |
| Ingredient: | morphine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 022195
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 022195
Suppliers and Packaging for NDA: 022195
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | morphine sulfate | SOLUTION;ORAL | 022195 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-0237 | 0054-0237-49 | 100 mL in 1 BOTTLE (0054-0237-49) |
| MORPHINE SULFATE | morphine sulfate | SOLUTION;ORAL | 022195 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-0237 | 0054-0237-63 | 500 mL in 1 BOTTLE (0054-0237-63) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/5ML | ||||
| Approval Date: | Mar 17, 2008 | TE: | AA | 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: | SOLUTION;ORAL | Strength | 20MG/5ML | ||||
| Approval Date: | Mar 17, 2008 | TE: | AA | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jun 2, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/5ML | ||||
| Approval Date: | Jan 25, 2010 | TE: | AA | RLD: | Yes | ||||
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