Registrants (1)
MDD US Operations, LLC
087875626
Manufacturing Establishments (5)
Catalent Pharma Solutions, LLC
Solstice Neurosciences, LLC
MDD US Operations, LLC
014167995
Eurofins Lancaster Laboratories, Inc.
Solstice Neurosciences, LLC
MDD US Operations, LLC
069777290
IDT Biologica GmbH
Solstice Neurosciences, LLC
MDD US Operations, LLC
332119734
Merz Pharma GmbH & Co. KGaA
Solstice Neurosciences, LLC
MDD US Operations, LLC
342543179
Pacific BioLabs
Solstice Neurosciences, LLC
MDD US Operations, LLC
797419769
Products (3)
Myobloc
10454-712
BLA103846
BLA (C73585)
INTRAMUSCULAR
December 20, 2023
ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACT
SODIUM SUCCINATE HEXAHYDRATEInactive
Code: U16QOD6C4EClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM CAPRYLATEInactive
Code: 9XTM81VK2BClass: IACT
N-ACETYL-DL-TRYPTOPHAN SODIUMInactive
Code: 3EN9H0M2FXClass: IACT
Botulinum toxin type BActive
Code: 0Y70779M1FClass: ACTIBQuantity: 10000 [USP'U] in 2 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Myobloc
10454-711
BLA103846
BLA (C73585)
INTRAMUSCULAR
December 20, 2023
SODIUM SUCCINATE HEXAHYDRATEInactive
Code: U16QOD6C4EClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CAPRYLATEInactive
Code: 9XTM81VK2BClass: IACT
N-ACETYL-DL-TRYPTOPHAN SODIUMInactive
Code: 3EN9H0M2FXClass: IACT
Botulinum toxin type BActive
Code: 0Y70779M1FClass: ACTIBQuantity: 5000 [USP'U] in 1 mL
Myobloc
10454-710
BLA103846
BLA (C73585)
INTRAMUSCULAR
December 20, 2023
SODIUM SUCCINATE HEXAHYDRATEInactive
Code: U16QOD6C4EClass: IACT
N-ACETYL-DL-TRYPTOPHAN SODIUMInactive
Code: 3EN9H0M2FXClass: IACT
ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACT
SODIUM CAPRYLATEInactive
Code: 9XTM81VK2BClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Botulinum toxin type BActive
Code: 0Y70779M1FClass: ACTIBQuantity: 2500 [USP'U] in 0.5 mL