Details for New Drug Application (NDA): 215337
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The generic ingredient in CARBOPROST TROMETHAMINE is carboprost tromethamine. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the carboprost tromethamine profile page.
Summary for 215337
Tradename: | CARBOPROST TROMETHAMINE |
Applicant: | Amneal |
Ingredient: | carboprost tromethamine |
Patents: | 0 |
Suppliers and Packaging for NDA: 215337
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARBOPROST TROMETHAMINE | carboprost tromethamine | INJECTABLE;INJECTION | 215337 | ANDA | Amneal Pharmaceuticals LLC | 70121-1680 | 70121-1680-7 | 10 VIAL in 1 CARTON (70121-1680-7) / 1 mL in 1 VIAL (70121-1680-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.25MG BASE/ML | ||||
Approval Date: | Jan 27, 2022 | TE: | AP | RLD: | No |
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