Home Applications 075800 Application 075800
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ETIDRONATE DISODIUM ETIDRONATE DISODIUM TABLET;ORAL 200MG No No 002 ETIDRONATE DISODIUM ETIDRONATE DISODIUM TABLET;ORAL 400MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075800-001 ETIDRONATE DISODIUM ETIDRONATE DISODIUM 200MG TABLET / ORAL 2003-01-24 A075800-002 ETIDRONATE DISODIUM ETIDRONATE DISODIUM 400MG TABLET / ORAL 2003-01-24
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 3 of 3 · 86 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 2022-09-29 23:25 UTC 2022-09 A075800-001 ETIDRONATE DISODIUM 200MG TABLET / ORAL 2003-01-24 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075800-002 ETIDRONATE DISODIUM 400MG TABLET / ORAL 2003-01-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075800-001 ETIDRONATE DISODIUM 200MG TABLET / ORAL 2003-01-24 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075800-002 ETIDRONATE DISODIUM 400MG TABLET / ORAL 2003-01-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075800-001 ETIDRONATE DISODIUM 200MG TABLET / ORAL 2003-01-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075800-002 ETIDRONATE DISODIUM 400MG TABLET / ORAL 2003-01-24 a50c72e98297…
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-3286 Etidronate Disodium etidronate disodium Mylan Pharmaceuticals Inc. ANDA Current 0378-3288 Etidronate Disodium etidronate disodium Mylan Pharmaceuticals Inc. ANDA Current 68151-1521 Etidronate Disodium etidronate disodium Carilion Materials Management ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 44270 ORIG 2008-01-07