Details for New Drug Application (NDA): 209429
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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 209429
| Tradename: | CYANOCOBALAMIN |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | cyanocobalamin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209429
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | cyanocobalamin | INJECTABLE;INJECTION | 209429 | ANDA | Henry Schein, Inc. | 0404-9783 | 0404-9783-30 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9783-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| CYANOCOBALAMIN | cyanocobalamin | INJECTABLE;INJECTION | 209429 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1703 | 51662-1703-3 | 10 POUCH in 1 CASE (51662-1703-3) / 1 VIAL in 1 POUCH (51662-1703-2) / 30 mL in 1 VIAL (51662-1703-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Dec 18, 2018 | TE: | AP | RLD: | No | ||||
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