Home Applications 079116 Application 079116
Type ANDA
Sponsor APOTEX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG No No 002 RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG No No 003 RAMIPRIL RAMIPRIL CAPSULE;ORAL 5MG No No 004 RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079116-001 RAMIPRIL RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 A079116-002 RAMIPRIL RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 A079116-003 RAMIPRIL RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 A079116-004 RAMIPRIL RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ramipril RAMIPRIL GSMS, Incorporated 62f6aa5a-7587-4349-b61d-b2c235749979 2025-07-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079116 application number: ANDA079116
Documents# Document, Submission type, Date table Document Submission type Date 23930 ORIG 2008-07-01