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 1 .
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 · 123 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 2026-02-19 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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