Details for New Drug Application (NDA): 214499
NDA 214499 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, Somerset Theraps Llc, and Sunny, and is included in thirteen NDAs. It is available from twenty-two 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-three 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-three suppliers are listed for this compound. Additional details are available on the carboprost tromethamine profile page.
Summary for 214499
| Tradename: | CARBOPROST TROMETHAMINE |
| Applicant: | Long Grove Pharms |
| Ingredient: | carboprost tromethamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214499
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBOPROST TROMETHAMINE | carboprost tromethamine | INJECTABLE;INJECTION | 214499 | ANDA | Long Grove Pharmaceuticals, LLC | 81298-5010 | 81298-5010-3 | 10 CARTON in 1 BOX (81298-5010-3) / 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-5010-1) / 1 mL in 1 VIAL, SINGLE-DOSE |
| CARBOPROST TROMETHAMINE | carboprost tromethamine | INJECTABLE;INJECTION | 214499 | ANDA | Long Grove Pharmaceuticals, LLC | 81298-5010 | 81298-5010-5 | 1 CARTON in 1 BOX (81298-5010-5) / 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-5010-1) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.25MG BASE/ML | ||||
| Approval Date: | Aug 9, 2022 | TE: | AP | RLD: | No | ||||
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