Apotex ANDA 210456 Approved Multiple Vitamins Injection Pediatric
Summary
FDA approved Abbreviated New Drug Application (ANDA) 210456 for MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) submitted by Apotex. The approval covers an injectable intravenous formulation containing 13 active ingredients including ascorbic acid, various B vitamins, vitamin A, vitamin D, vitamin E, and vitamin K at specified strengths per vial. The product received TE Code AP (bioequivalence Rating AP) and carries Prescription marketing status but is not listed as a Reference Listed Drug (RLD) or Reference Standard (RS).
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What changed
FDA granted approval to Apotex for ANDA 210456 covering Multiple Vitamins Injection Pediatric (Pharmacy Bulk Package), an injectable intravenous product containing multiple vitamins at specified concentrations per vial. The approval is classified as STANDARD review priority with no orphan drug status. The product bears TE Code AP (bioequivalence rating AP), indicating therapeutic equivalence to approved reference products.
Pharmaceutical companies, healthcare providers, and pharmacies should note this new pediatric vitamin injection is now available for prescribing and dispensing as a Prescription product. The pharmacy bulk package formulation may be relevant for institutional settings requiring multi-dose preparation. Generic competition in this therapeutic category may intensify as additional ANDA approvals follow.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Abbreviated New Drug Application (ANDA): 210456
Company: APOTEX
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| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/21/2026 | ORIG-1 | Approval | STANDARD | Label is not available on this site. |
MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE)
INJECTABLE;INTRAVENOUS; 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 210456 | APOTEX |
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