Application 020472

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRINGESTRADIOLINSERT, EXTENDED RELEASE;VAGINAL0.0075MG/24HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0013-2150EstringestradiolPfizer Laboratories Div Pfizer IncNDACurrent
0013-2150EstringestradiolPharmacia and Upjohn Company LLCNDACurrent
0013-2150EstringestradiolPharmacia and Upjohn Company LLCNDACurrent
63539-021EstringestradiolU.S. PharmaceuticalsNDACurrent
63539-021EstringestradiolU.S. PharmaceuticalsNDACurrent
63539-021EstringestradiolU.S. PharmaceuticalsNDACurrent
63539-021EstringestradiolU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85031SUPPL 2026-02-12
85017SUPPL 2026-02-12
77576SUPPL 2024-02-20
77557SUPPL 2024-02-16
77556SUPPL 2024-02-16
74120ORIG 2023-04-28
71728SUPPL2022-08-05
71650SUPPL2022-07-28
57108ORIG2019-01-03
50300SUPPL2017-11-06
50274SUPPL2017-11-02
34685SUPPL2015-12-10
12617SUPPL2015-12-10
25013SUPPL2015-09-30
2575SUPPL2015-09-30
2574SUPPL2014-08-14
34684SUPPL2014-08-13
41385SUPPL2009-01-12
20672SUPPL2009-01-12
20671SUPPL2009-01-12
34683SUPPL2008-08-29
25012SUPPL2008-08-27