Details for New Drug Application (NDA): 205758
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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 205758
Tradename: | MORPHINE SULFATE |
Applicant: | Hikma |
Ingredient: | morphine sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205758
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 205758
Suppliers and Packaging for NDA: 205758
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | morphine sulfate | INJECTABLE;INJECTION | 205758 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6125 | 0641-6125-25 | 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-6125-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6125-01) |
MORPHINE SULFATE | morphine sulfate | INJECTABLE;INJECTION | 205758 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6126 | 0641-6126-25 | 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-6126-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6126-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4MG/ML | ||||
Approval Date: | May 21, 2015 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 8MG/ML | ||||
Approval Date: | May 21, 2015 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
Approval Date: | May 21, 2015 | TE: | AP | RLD: | No |
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