Details for New Drug Application (NDA): 018565
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NDA 018565 describes INFUMORPH, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the INFUMORPH profile page.
The generic ingredient in INFUMORPH 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.
The generic ingredient in INFUMORPH 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 018565
| Tradename: | INFUMORPH |
| Applicant: | Hikma |
| Ingredient: | morphine sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018565
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 018565
Suppliers and Packaging for NDA: 018565
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DURAMORPH PF | morphine sulfate | INJECTABLE;INJECTION | 018565 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6019 | 0641-6019-10 | 10 AMPULE in 1 CARTON (0641-6019-10) / 10 mL in 1 AMPULE (0641-6019-01) |
| DURAMORPH PF | morphine sulfate | INJECTABLE;INJECTION | 018565 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6020 | 0641-6020-10 | 10 AMPULE in 1 CARTON (0641-6020-10) / 10 mL in 1 AMPULE (0641-6020-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/ML | ||||
| Approval Date: | Sep 18, 1984 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Sep 18, 1984 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Jul 19, 1991 | TE: | AP | RLD: | Yes | ||||
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