FDA.reportPublic FDA data

Application 021344

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FASLODEXFULVESTRANTINJECTABLE;INTRAMUSCULAR50MG/MLYesYes
002FASLODEXFULVESTRANTSOLUTION;INTRAMUSCULAR125MG/2.5ML (50MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-0720FASLODEXFulvestrantAstraZeneca Pharmaceuticals LPNDACurrent
0310-0720FASLODEXFulvestrantAstraZeneca Pharmaceuticals LPNDACurrent
0310-0720FASLODEXFulvestrantAstraZeneca Pharmaceuticals LPNDACurrent
0310-0720FASLODEXFulvestrantAstraZeneca Pharmaceuticals LPNDACurrent
0310-0720FASLODEXFulvestrantAstraZeneca Pharmaceuticals LPNDACurrent
0310-0720FASLODEXFulvestrantAstraZeneca Pharmaceuticals LPNDACurrent
0310-0720FASLODEXFulvestrantAstraZeneca Pharmaceuticals LPNDACurrent
0310-0720FASLODEXFulvestrantAstraZeneca Pharmaceuticals LPNDACurrent
0310-0720FASLODEXFulvestrantAstraZeneca Pharmaceuticals LPNDACurrent
0310-0720FASLODEXFulvestrantAstraZeneca Pharmaceuticals LPNDACurrent
0310-7720FulvestrantFulvestrantAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-7720FulvestrantFulvestrantAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-7720FulvestrantFulvestrantAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-7720FulvestrantFulvestrantAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-7720FulvestrantFulvestrantAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65952SUPPL2021-01-21
65946SUPPL2021-01-21
64131SUPPL2020-07-30
64121SUPPL2020-07-29
62994SUPPL2020-05-14
62975SUPPL2020-05-13
61030SUPPL2019-11-22
61016SUPPL2019-11-22
60035SUPPL2019-09-23
60058SUPPL2019-09-20
60055SUPPL2019-09-20
58828SUPPL2019-05-22
58819SUPPL2019-05-21
57966SUPPL2019-03-12
57964SUPPL2019-03-12
54914SUPPL2018-07-19
54777SUPPL2018-07-06
52788SUPPL2018-03-01
52653SUPPL2018-02-15
50420SUPPL2017-11-15
50412SUPPL2017-11-15
49557SUPPL2017-08-28
49551SUPPL2017-08-28
46995SUPPL2017-01-27
45731SUPPL2016-10-31
15232SUPPL2016-07-13
5103SUPPL2016-07-13
36707SUPPL2016-05-23
5102SUPPL2016-05-20
15231SUPPL2016-03-04
5101SUPPL2016-03-04
36706SUPPL2016-03-03
5100SUPPL2016-03-03
27535SUPPL2012-11-13
5099SUPPL2012-11-13
36705SUPPL2012-11-08
15230SUPPL2012-11-08
15229SUPPL2012-07-25
27534SUPPL2012-07-17
27533SUPPL2011-09-29
5098SUPPL2011-09-29
36704SUPPL2011-09-26
36703SUPPL2011-09-26
15228SUPPL2011-05-23
27532SUPPL2011-05-19
51928SUPPL2011-02-01
51927SUPPL2011-02-01
51926SUPPL2011-02-01
51925SUPPL2011-02-01
51924SUPPL2011-02-01
51923SUPPL2011-02-01
5097SUPPL2010-09-13
5096SUPPL2010-09-13
15227SUPPL2010-09-10
15226SUPPL2010-09-10
36702SUPPL2005-08-08
27531SUPPL2005-08-08
36701SUPPL2004-01-15
5095SUPPL2004-01-14
42113ORIG2002-04-25
36700ORIG2002-04-25
27530ORIG2002-04-25