Application 008453

Type
NDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANECTINESUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION500MG/VIALNoNo
002ANECTINESUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION20MG/MLYesYes
003ANECTINESUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION50MG/MLNoNo
004ANECTINESUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION1GM/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3009AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-3411AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-3411AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-3411AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-3411AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-3411AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-3411AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-3411AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-3411AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-9053AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-9053AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-9053AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-9053AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-9053AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
0781-9053AnectineSuccinylcholine ChlorideSandoz IncNDACurrent
72572-750AnectineSuccinylcholine ChlorideCivica, Inc.NDACurrent
72572-750AnectineSuccinylcholine ChlorideCivica, Inc.NDACurrent
72572-750AnectineSuccinylcholine ChlorideCivica, Inc.NDACurrent
72572-750AnectineSuccinylcholine ChlorideCivica, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72540SUPPL2022-11-02
72528SUPPL2022-11-02
65693SUPPL2020-12-22
55042SUPPL2018-07-30
55028SUPPL2018-07-27
101SUPPL2010-11-30
10703SUPPL2010-11-22
20013SUPPL2000-06-12
20012SUPPL2000-06-12
20011SUPPL2000-06-12
20010SUPPL2000-06-12