Details for New Drug Application (NDA): 216882
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NDA 216882 describes CARBOPROST TROMETHAMINE, which is a drug marketed by Alembic, Amneal, Ani Pharms, Caplin, Dr Reddys, Eugia Pharma, Gland, Long Grove Pharms, Micro Labs, Onesource Specialty, Sola Pharms, and Sunny, and is included in twelve NDAs. It is available from twenty suppliers. Additional details are available on the CARBOPROST TROMETHAMINE profile page.
The generic ingredient in CARBOPROST TROMETHAMINE is carboprost tromethamine. There is one drug master file entry for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the carboprost tromethamine profile page.
The generic ingredient in CARBOPROST TROMETHAMINE is carboprost tromethamine. There is one drug master file entry for this compound. Twenty-one 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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