FDA.report

Application 021673

Type
NDA
Sponsor
GENZYME

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001CLOLARCLOFARABINESOLUTION;INTRAVENOUS20MG/20ML (1MG/ML)YesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5860ClolarclofarabineSanofi-Aventis U.S. LLCNDACurrent
0024-5860Clolarclofarabinesanofi-aventis U.S. LLCNDACurrent
0024-5860ClolarclofarabineSanofi-Aventis U.S. LLCNDACurrent
0024-5860ClolarclofarabineSanofi-Aventis U.S. LLCNDACurrent
0024-5860ClolarclofarabineSanofi-Aventis U.S. LLCNDACurrent
0024-5860ClolarclofarabineSanofi-Aventis U.S. LLCNDACurrent
0024-5917Clolarclofarabinesanofi-aventis U.S. LLCNDACurrent
0024-5917ClolarclofarabineSanofi-Aventis U.S. LLCNDACurrent
0955-1746clofarabineclofarabineWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1746ClofarabineclofarabineWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1746clofarabineclofarabineWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1746clofarabineclofarabinesanofi-aventis U.S. LLCNDA AUTHORIZED GENERICCurrent
0955-1746clofarabineclofarabineWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1746ClofarabineclofarabineWinthrop U.S.NDA AUTHORIZED GENERICCurrent

Documents

DocumentSubmission typeDate
71599SUPPL2022-07-19
71587SUPPL2022-07-19
61435SUPPL2019-12-26
61420SUPPL2019-12-23
45749SUPPL2016-11-01
45734SUPPL2016-10-31
5959SUPPL2015-12-18
15957SUPPL2015-12-17
15956SUPPL2014-09-19
5958SUPPL2014-09-17
28349SUPPL2013-01-14
37435SUPPL2013-01-11
28348SUPPL2011-06-15
15955SUPPL2011-06-14
28347SUPPL2008-10-23
28346SUPPL2008-10-23
21775ORIG2005-04-05
37434ORIG2004-12-29
28345ORIG2004-12-29
51829ORIG1900-01-01
51828ORIG1900-01-01
51827ORIG1900-01-01
51826ORIG1900-01-01
51825ORIG1900-01-01