FDA.reportPublic FDA data

Application 065125

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 250MG BASE/VIALNoNo
002CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 500MG BASE/VIALNoNo
003CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 1GM BASE/VIALNoNo
004CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10019-098CeftriaxoneCeftriaxone SodiumBAXTER HEALTHCARE CORPORAANDACurrent
50090-0945CEFTRIAXONECEFTRIAXONEA-S Medication SolutionsANDACurrent
50090-0945CEFTRIAXONECEFTRIAXONEA-S Medication SolutionsANDACurrent
50090-1773CEFTRIAXONECEFTRIAXONEA-S Medication SolutionsANDACurrent
57297-611CEFTRIAXONECEFTRIAXONELUPIN LIMITEDANDACurrent
57297-622CEFTRIAXONECEFTRIAXONELUPIN LIMITEDANDACurrent
57297-633CEFTRIAXONECEFTRIAXONELUPIN LIMITEDANDACurrent
57297-644CEFTRIAXONECEFTRIAXONELUPIN LIMITEDANDACurrent
63187-435CEFTRIAXONECEFTRIAXONEProficient Rx LPANDACurrent
63187-435CEFTRIAXONECEFTRIAXONEProficient Rx LPANDACurrent
63187-435CEFTRIAXONECEFTRIAXONEProficient Rx LPANDACurrent
63187-435CEFTRIAXONECEFTRIAXONEProficient Rx LPANDACurrent
68071-4303CEFTRIAXONECEFTRIAXONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4303CEFTRIAXONECEFTRIAXONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4304CEFTRIAXONECEFTRIAXONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4304CEFTRIAXONECEFTRIAXONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4713CEFTRIAXONECEFTRIAXONENuCare Pharmaceuticals,InANDACurrent
68071-4713CEFTRIAXONECEFTRIAXONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4713CEFTRIAXONECEFTRIAXONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4715CEFTRIAXONECEFTRIAXONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4715CEFTRIAXONECEFTRIAXONENuCare Pharmaceuticals,InANDACurrent
68071-4715CEFTRIAXONECEFTRIAXONENuCare Pharmaceuticals,Inc.ANDACurrent
68180-611CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-611CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-611CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-611CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-622CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-622CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-622CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-622CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-633CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-633CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-633CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-633CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-644CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-644CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-644CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
68180-644CEFTRIAXONECEFTRIAXONELupin Pharmaceuticals, Inc.ANDACurrent
71205-117CEFTRIAXONECEFTRIAXONEProficient Rx LPANDACurrent
71205-117CEFTRIAXONECEFTRIAXONEProficient Rx LPANDACurrent
71205-117CEFTRIAXONECEFTRIAXONEProficient Rx LPANDACurrent
71205-117CEFTRIAXONECEFTRIAXONEProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44211ORIG2008-09-19
22314ORIG2005-07-22