FDA.reportPublic FDA data

Application 020496

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMARYLGLIMEPIRIDETABLET;ORAL1MGYesYes
002AMARYLGLIMEPIRIDETABLET;ORAL2MGYesNo
003AMARYLGLIMEPIRIDETABLET;ORAL4MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0039-0221AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent
0039-0221AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent
0039-0222AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent
0039-0222AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent
0039-0223AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent
0039-0223AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57651ORIG2019-02-15
57073SUPPL2018-12-31
57013SUPPL2018-12-26
46490SUPPL2016-12-22
46494SUPPL2016-12-21
12637SUPPL2013-10-22
25049SUPPL2013-10-18
12636SUPPL2013-08-09
25048SUPPL2013-08-05
25047SUPPL2012-02-08
34713SUPPL2012-02-06
25046SUPPL2009-06-16
34712SUPPL2009-06-04
25045SUPPL2009-02-13
2603SUPPL2009-02-13
34711SUPPL2009-02-04
12635SUPPL2009-02-04
25044SUPPL2005-12-06
34709SUPPL2005-12-05
34710SUPPL2005-09-22
2602SUPPL2005-09-22
25043SUPPL2004-08-25
20684SUPPL2004-05-27
2601SUPPL2002-04-15
20683SUPPL1999-02-24
2600SUPPL1999-02-24
51967SUPPL1900-01-01
51966SUPPL1900-01-01
51965SUPPL1900-01-01