Details for New Drug Application (NDA): 214655
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The generic ingredient in CYANOCOBALAMIN is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.
Summary for 214655
Tradename: | CYANOCOBALAMIN |
Applicant: | Zydus Pharms |
Ingredient: | cyanocobalamin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214655
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYANOCOBALAMIN | cyanocobalamin | INJECTABLE;INJECTION | 214655 | ANDA | Northstar Rx LLC. | 16714-165 | 16714-165-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (16714-165-25) / 1 mL in 1 VIAL, MULTI-DOSE (16714-165-01) |
CYANOCOBALAMIN | cyanocobalamin | INJECTABLE;INJECTION | 214655 | ANDA | Northstar Rx LLC. | 16714-302 | 16714-302-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (16714-302-10) / 10 mL in 1 VIAL, MULTI-DOSE (16714-302-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
Approval Date: | Apr 15, 2022 | TE: | AP | RLD: | No |
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