Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Piramal Critical Care, Inc.
805600439
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Patheon Manufacturing Services LLC
Piramal Critical Care, Inc.
Piramal Critical Care, Inc.
079415560
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MITIGO
Product Details
NDC Product Code
66794-162Application Number
ANDA204393Marketing Category
ANDA (C73584)Route of Administration
EPIDURAL, INTRATHECALEffective Date
December 27, 2023WATERInactive
Code: 059QF0KO0RClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 500 mg in 20 mL
MITIGO
Product Details
NDC Product Code
66794-160Application Number
ANDA204393Marketing Category
ANDA (C73584)Route of Administration
EPIDURAL, INTRATHECALEffective Date
December 27, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 200 mg in 20 mL
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT