FDA.reportPublic FDA data

Application 020907

Type
NDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACTIVELLAESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL1MG;0.5MGYesYes
002ACTIVELLAESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL0.5MG;0.1MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60846-201Activellaestradiol and norethindrone acetateGemini Laboratories, LLCNDACurrent
60846-202Activellaestradiol and norethindrone acetateGemini Laboratories, LLCNDACurrent
60846-231ActivellaEstradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDACurrent
60846-231ActivellaEstradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDACurrent
60846-231ActivellaEstradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDACurrent
60846-231ActivellaEstradiol/norethindrone acetateGemini Laboratories, LLCNDACurrent
60846-232ActivellaEstradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDACurrent
60846-232ActivellaEstradiol/norethindrone acetateGemini Laboratories, LLCNDACurrent
60846-232ActivellaEstradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDACurrent
60846-232ActivellaEstradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDACurrent
60846-232ActivellaEstradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDACurrent
60846-232ActivellaEstradiol/norethindrone acetateGemini Laboratories, LLCNDACurrent
69238-1251Lopreezaestradiol/norethindrone acetateAmneal Pharmaceuticals NY LLCNDA AUTHORIZED GENERICCurrent
69238-1251Lopreezaestradiol/norethindrone acetateAmneal Pharmaceuticals NY LLCNDA AUTHORIZED GENERICCurrent
69238-1251Lopreezaestradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
69238-1251Lopreezaestradiol/norethindrone acetateAmneal Pharmaceuticals NY LLCNDA AUTHORIZED GENERICCurrent
69238-1252Lopreezaestradiol/norethindrone acetateAmneal Pharmaceuticals NY LLCNDA AUTHORIZED GENERICCurrent
69238-1252Lopreezaestradiol/norethindrone acetateAmneal Pharmaceuticals NY LLCNDA AUTHORIZED GENERICCurrent
69238-1252Lopreezaestradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
69238-1252Lopreezaestradiol/norethindrone acetateAmneal Pharmaceuticals NY LLCNDA AUTHORIZED GENERICCurrent
69238-1609LOPREEZAestradiol/norethindrone acetateAmneal Pharmaceuticals NY LLCNDACurrent
69238-1609LOPREEZAestradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDACurrent
69238-1610LOPREEZAestradiol/norethindrone acetateAmneal Pharmaceuticals NY LLCNDACurrent
69238-1610LOPREEZAestradiol/norethindrone acetateAmneal Pharmaceuticals LLCNDACurrent
69238-1610LOPREEZAestradiol/norethindrone acetateAmneal Pharmaceuticals NY LLCNDACurrent
69238-1610LOPREEZAestradiol/norethindrone acetateAmneal Pharmaceuticals NY LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77527SUPPL 2024-02-16
77520SUPPL 2024-02-16
68347SUPPL2021-08-11
68336SUPPL2021-08-11
68334SUPPL2021-08-11
62510SUPPL2020-04-09
50631SUPPL2017-12-07
50291SUPPL2017-11-03
13724SUPPL2013-10-17
26174SUPPL2013-10-10
35625SUPPL2007-01-08
35624SUPPL2007-01-08
26173SUPPL2007-01-08
26172SUPPL2007-01-08
41805SUPPL2005-12-08
41804SUPPL2005-12-08
41803SUPPL2005-12-08
41802SUPPL2005-12-08
21271SUPPL2005-12-08
21270SUPPL2005-12-08
26171SUPPL2005-07-08
35623SUPPL2005-07-07
41801ORIG1998-11-18
35622ORIG1998-11-18
26170ORIG1998-11-18