Details for New Drug Application (NDA): 212458
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NDA 212458 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 Pharma Ltd, Luitpold, Lyphomed, Mankind Pharma, Mylan Institutional, Mylan Labs Ltd, 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 NDAs. It is available from twenty-two 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 212458
| Tradename: | CYANOCOBALAMIN |
| Applicant: | Padagis Israel |
| Ingredient: | cyanocobalamin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212458
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | cyanocobalamin | SPRAY, METERED;NASAL | 212458 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-491 | 45802-491-84 | 4 BOTTLE, UNIT-DOSE in 1 CARTON (45802-491-84) / 1 SPRAY in 1 BOTTLE, UNIT-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.5MG/SPRAY | ||||
| Approval Date: | Sep 9, 2020 | TE: | AB | RLD: | No | ||||
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