Details for New Drug Application (NDA): 204393
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NDA 204393 describes MITIGO, which is a drug marketed by Piramal Critical and is included in one NDA. It is available from one supplier. Additional details are available on the MITIGO profile page.
The generic ingredient in MITIGO 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 MITIGO 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 204393
| Tradename: | MITIGO |
| Applicant: | Piramal Critical |
| Ingredient: | morphine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 204393
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 204393
Suppliers and Packaging for NDA: 204393
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MITIGO | morphine sulfate | INJECTABLE;INJECTION | 204393 | ANDA | Piramal Critical Care, Inc. | 66794-160 | 66794-160-02 | 1 mL in 1 VIAL, SINGLE-USE (66794-160-02) |
| MITIGO | morphine sulfate | INJECTABLE;INJECTION | 204393 | ANDA | Piramal Critical Care, Inc. | 66794-162 | 66794-162-02 | 1 mL in 1 VIAL, SINGLE-USE (66794-162-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Jul 16, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/ML | ||||
| Approval Date: | Jul 16, 2018 | TE: | AP | RLD: | No | ||||
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