Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
HF Acquisition Co LLC, DBA HealthFirst
045657305
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
045657305
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEXAMETHASONE SODIUM PHOSPHATE
Product Details
NDC Product Code
51662-1297Application Number
ANDA084282Marketing Category
ANDA (C73584)Route of Administration
SOFT TISSUE, INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUSEffective Date
January 30, 2024SODIUM SULFITEInactive
Code: VTK01UQK3GClass: IACTQuantity: 1 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
DexamethasoneActive
Code: AI9376Y64PClass: ACTIRQuantity: 4 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 19.4 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10.42 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT