Details for New Drug Application (NDA): 213874
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NDA 213874 describes CYANOCOBALAMIN, which is a drug marketed by Abraxis Pharm, Am Regent, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Luitpold, Lyphomed, Mankind Pharma, Meitheal, Mylan Institutional, Pharmobedient, Sagent Pharms Inc, Sandoz, Sanofi Aventis Us, Sola Pharms, Solopak, Somerset Theraps Llc, Vitruvias Therap, Warner Chilcott, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Xiromed, Zydus Pharms, Lupin, Padagis Israel, and West Ward, and is included in thirty-one NDAs. It is available from twenty-three suppliers. Additional details are available on the CYANOCOBALAMIN profile page.
The generic ingredient in CYANOCOBALAMIN is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.
The generic ingredient in CYANOCOBALAMIN is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.
Summary for 213874
| Tradename: | CYANOCOBALAMIN |
| Applicant: | Eugia Pharma |
| Ingredient: | cyanocobalamin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213874
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | cyanocobalamin | INJECTABLE;INJECTION | 213874 | ANDA | AuroMedics Pharma LLC | 55150-364 | 55150-364-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-364-01) / 1 mL in 1 VIAL, MULTI-DOSE |
| CYANOCOBALAMIN | cyanocobalamin | INJECTABLE;INJECTION | 213874 | ANDA | AuroMedics Pharma LLC | 55150-364 | 55150-364-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (55150-364-10) / 1 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Dec 8, 2020 | TE: | AP | RLD: | No | ||||
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