FDA.reportPublic FDA data

Application 020955

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FERRLECITSODIUM FERRIC GLUCONATE COMPLEXINJECTABLE;INJECTION62.5MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-2792Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2792Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2792Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2792Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2792Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2792Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2792Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2792Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2792Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2794Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2794Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2794Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2794Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2794Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2794Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2794Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent
0024-2794Ferrlecitsodium ferric gluconate complexsanofi-aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70543SUPPL2022-03-17
70538SUPPL2022-03-17
65498SUPPL2020-12-04
65491SUPPL2020-12-03
62421SUPPL2020-04-02
62405SUPPL2020-04-01
35718SUPPL2011-08-26
35717SUPPL2011-08-26
26297SUPPL2011-08-26
26296SUPPL2011-08-26
41838SUPPL2007-04-30
21302SUPPL2007-04-30
26295SUPPL2006-10-05
13812SUPPL2006-10-05
35716SUPPL2004-08-25
3845SUPPL2004-08-25
3844SUPPL2003-07-23
35715SUPPL2003-04-25
26294SUPPL2002-06-07
41837ORIG1999-02-18
35714ORIG1999-02-18
26293ORIG1999-02-18
52206SUPPL1900-01-01
52205SUPPL1900-01-01
52204SUPPL1900-01-01
52203SUPPL1900-01-01