Details for New Drug Application (NDA): 215194
✉ Email this page to a colleague
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 215194
Tradename: | MORPHINE SULFATE |
Applicant: | Specgx Llc |
Ingredient: | morphine sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215194
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 215194
Suppliers and Packaging for NDA: 215194
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | morphine sulfate | TABLET;ORAL | 215194 | ANDA | SpecGx LLC | 0406-5118 | 0406-5118-01 | 100 TABLET in 1 BOTTLE (0406-5118-01) |
MORPHINE SULFATE | morphine sulfate | TABLET;ORAL | 215194 | ANDA | SpecGx LLC | 0406-5118 | 0406-5118-62 | 10 BLISTER PACK in 1 CARTON (0406-5118-62) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Aug 21, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Aug 21, 2023 | TE: | AB | RLD: | No |
Complete Access Available with Subscription