Details for New Drug Application (NDA): 216897
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NDA 216897 describes CARBOPROST TROMETHAMINE, which is a drug marketed by Alembic, Amneal, Ani Pharms, Caplin, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Long Grove Pharms, Micro Labs, Sola Pharms, Steriscience Speclts, and Sunny, and is included in twelve NDAs. It is available from seventeen 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. Eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the carboprost tromethamine profile page.
Summary for 216897
| Tradename: | CARBOPROST TROMETHAMINE |
| Applicant: | Steriscience Speclts |
| Ingredient: | carboprost tromethamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216897
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBOPROST TROMETHAMINE | carboprost tromethamine | INJECTABLE;INJECTION | 216897 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-112 | 70594-112-02 | 10 VIAL in 1 CARTON (70594-112-02) / 1 mL in 1 VIAL (70594-112-01) |
| CARBOPROST TROMETHAMINE | carboprost tromethamine | INJECTABLE;INJECTION | 216897 | ANDA | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-002 | 83270-002-02 | 10 VIAL in 1 CARTON (83270-002-02) / 1 mL in 1 VIAL (83270-002-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.25MG BASE/ML | ||||
| Approval Date: | Jul 25, 2023 | TE: | AP | RLD: | No | ||||
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