Home Applications 076483 Application 076483
Type ANDA
Sponsor UPSHER SMITH LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FOSINOPRIL SODIUM FOSINOPRIL SODIUM TABLET;ORAL 10MG No No 002 FOSINOPRIL SODIUM FOSINOPRIL SODIUM TABLET;ORAL 20MG No No 003 FOSINOPRIL SODIUM FOSINOPRIL SODIUM TABLET;ORAL 40MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A076483-001 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 A076483-002 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 A076483-003 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 1 of 4 · 126 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 2026-08-18 06:07:40 2026-07 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0185-0041 Fosinopril Sodium Fosinopril Sodium Eon Labs, Inc. ANDA Current 0185-0042 Fosinopril Sodium Fosinopril Sodium Eon Labs, Inc. ANDA Current 0185-0047 Fosinopril Sodium Fosinopril Sodium Eon Labs, Inc. ANDA Current 50090-0890 Fosinopril Sodium Fosinopril Sodium A-S Medication Solutions ANDA Current 67544-306 Fosinopril Sodium Fosinopril Sodium Aphena Pharma Solutions - Tennessee, Inc. ANDA Current 67544-322 Fosinopril Sodium Fosinopril Sodium Aphena Pharma Solutions - Tennessee, Inc. ANDA Current 68258-6106 Fosinopril Sodium Fosinopril Sodium Dispensing Solutions, Inc. ANDA Current