Details for New Drug Application (NDA): 022041
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The generic ingredient in CYANOKIT is hydroxocobalamin. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydroxocobalamin profile page.
Summary for 022041
Tradename: | CYANOKIT |
Applicant: | Btg Intl |
Ingredient: | hydroxocobalamin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 022041
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYANOKIT | hydroxocobalamin | INJECTABLE;INJECTION | 022041 | NDA | Meridian Medical Technologies, Inc. | 11704-370 | 11704-370-01 | 1 VIAL, GLASS in 1 CARTON (11704-370-01) / 250 mL in 1 VIAL, GLASS |
CYANOKIT | hydroxocobalamin | INJECTABLE;INJECTION | 022041 | NDA | BTG INTERNATIONAL INC. | 50633-310 | 50633-310-11 | 1 VIAL, GLASS in 1 CARTON (50633-310-11) / 250 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/VIAL (5GM/KIT) | ||||
Approval Date: | Apr 8, 2011 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/VIAL (5GM/KIT) | ||||
Approval Date: | Dec 15, 2006 | TE: | RLD: | No |
Expired US Patents for NDA 022041
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Btg Intl | CYANOKIT | hydroxocobalamin | INJECTABLE;INJECTION | 022041-001 | Apr 8, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Btg Intl | CYANOKIT | hydroxocobalamin | INJECTABLE;INJECTION | 022041-002 | Dec 15, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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