FDA.reportPublic FDA data

Application 085470

Type
ANDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPO-ESTRADIOLESTRADIOL CYPIONATEINJECTABLE;INJECTION1MG/MLNoNo
002DEPO-ESTRADIOLESTRADIOL CYPIONATEINJECTABLE;INJECTION3MG/MLNoNo
003DEPO-ESTRADIOLESTRADIOL CYPIONATEINJECTABLE;INJECTION5MG/MLNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085470-001DEPO-ESTRADIOLESTRADIOL CYPIONATE1MG/MLINJECTABLE / INJECTIONApproved before 1982
A085470-002DEPO-ESTRADIOLESTRADIOL CYPIONATE3MG/MLINJECTABLE / INJECTIONApproved before 1982
A085470-003DEPO-ESTRADIOLESTRADIOL CYPIONATE5MG/MLINJECTABLE / INJECTIONRS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085470-002DEPO-ESTRADIOL3MG/MLINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085470-003DEPO-ESTRADIOL5MG/MLINJECTABLE / INJECTIONRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085470-001DEPO-ESTRADIOL1MG/MLINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Depo-EstradiolESTRADIOL CYPIONATEPharmacia & Upjohn Company LLC9a4229fd-fecd-4ac1-9c4f-6d442533457f2024-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085470
application number: ANDA085470
ndc (product): 0009-0271

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0271Depo-Estradiolestradiol cypionatePharmacia and Upjohn Company LLCANDACurrent
0009-0271Depo-Estradiolestradiol cypionatePharmacia & Upjohn Company LLCANDACurrent
0009-0271Depo-Estradiolestradiol cypionatePharmacia and Upjohn Company LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39588SUPPL2009-09-30