Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Xiromed Pharma Espana, S.L.
468835741
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Laboratorios Farmalan, S.A. (Chemo)
Xiromed, LLC
Xiromed Pharma Espana, S.L.
468284866
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Estradiol valerate
Product Details
NDC Product Code
70700-273Application Number
ANDA216656Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
September 14, 2021CHLOROBUTANOLInactive
Code: HM4YQM8WRCClass: IACT
Estradiol valerateActive
Code: OKG364O896Class: ACTIBQuantity: 10 mg in 1 mL
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
Estradiol valerate
Product Details
NDC Product Code
70700-274Application Number
ANDA216656Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
September 14, 2021Estradiol valerateActive
Code: OKG364O896Class: ACTIBQuantity: 20 mg in 1 mL
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
CASTOR OILInactive
Code: D5340Y2I9GClass: IACT
Estradiol valerate
Product Details
NDC Product Code
70700-275Application Number
ANDA216656Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
September 14, 2021Estradiol valerateActive
Code: OKG364O896Class: ACTIBQuantity: 40 mg in 1 mL
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
CASTOR OILInactive
Code: D5340Y2I9GClass: IACT