Details for New Drug Application (NDA): 216882
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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 216882
Tradename: | CARBOPROST TROMETHAMINE |
Applicant: | Caplin |
Ingredient: | carboprost tromethamine |
Patents: | 0 |
Suppliers and Packaging for NDA: 216882
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARBOPROST TROMETHAMINE | carboprost tromethamine | INJECTABLE;INJECTION | 216882 | ANDA | Caplin Steriles Limited | 65145-132 | 65145-132-10 | 10 VIAL in 1 CARTON (65145-132-10) / 1 mL in 1 VIAL (65145-132-01) |
CARBOPROST TROMETHAMINE | carboprost tromethamine | INJECTABLE;INJECTION | 216882 | ANDA | Fresenius Kabi USA, LLC | 65219-579 | 65219-579-01 | 10 VIAL in 1 CARTON (65219-579-01) / 1 mL in 1 VIAL (65219-579-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.25MG BASE/ML | ||||
Approval Date: | Feb 13, 2023 | TE: | AP | RLD: | No |
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