Home Applications 009402 Application 009402
Type NDA
Sponsor PAR STERILE PRODUCTS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 DELESTROGEN ESTRADIOL VALERATE INJECTABLE;INJECTION 10MG/ML Yes Yes 003 DELESTROGEN ESTRADIOL VALERATE INJECTABLE;INJECTION 40MG/ML Yes Yes 004 DELESTROGEN ESTRADIOL VALERATE INJECTABLE;INJECTION 20MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N009402-002 DELESTROGEN ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 N009402-003 DELESTROGEN ESTRADIOL VALERATE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 N009402-004 DELESTROGEN ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 4 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N009402-002 DELESTROGEN 10MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N009402-003 DELESTROGEN 40MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N009402-004 DELESTROGEN 20MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N009402-002 DELESTROGEN 10MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N009402-003 DELESTROGEN 40MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N009402-004 DELESTROGEN 20MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009402-002 DELESTROGEN 10MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009402-003 DELESTROGEN 40MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009402-004 DELESTROGEN 20MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009402-002 DELESTROGEN 10MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009402-003 DELESTROGEN 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009402-004 DELESTROGEN 20MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 115 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42023-110 Delestrogen estradiol valerate Par Pharmaceutical, Inc. NDA Current 42023-110 Delestrogen estradiol valerate Par Pharmaceutical, Inc. NDA Current 42023-111 Delestrogen estradiol valerate Par Pharmaceutical, Inc. NDA Current 42023-111 Delestrogen estradiol valerate Par Pharmaceutical, Inc. NDA Current 42023-112 Delestrogen estradiol valerate Par Pharmaceutical, Inc. NDA Current 42023-112 Delestrogen estradiol valerate Par Pharmaceutical, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 77565 SUPPL 2024-02-20 77542 SUPPL 2024-02-16 70232 SUPPL 2022-02-23 70180 SUPPL 2022-02-17 50306 SUPPL 2017-11-06 50267 SUPPL 2017-11-02 191 SUPPL 2007-10-15 33002 SUPPL 2004-07-28 190 SUPPL 2004-07-28 10728 SUPPL 2004-06-02 33001 SUPPL 2003-12-16 189 SUPPL 2003-12-16 188 SUPPL 2003-12-16