Home Applications 091604 Application 091604
Type ANDA
Sponsor AUROBINDO PHARMA LTD 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 44 .
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 A091604-001 RAMIPRIL RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 A091604-002 RAMIPRIL RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 A091604-003 RAMIPRIL RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 A091604-004 RAMIPRIL RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08
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 · 176 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 2026-10-15 13:18:30 2026-09 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 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 2 of 2 · 21 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 2 of 2 · 95 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70518-3038 Ramipril Ramipril REMEDYREPACK INC. ANDA Current 70934-460 Ramipril Ramipril Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-460 Ramipril Ramipril Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-691 Ramipril Ramipril Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 71205-029 Ramipril Ramipril Proficient Rx LP ANDA Current 71205-029 Ramipril Ramipril Proficient Rx LP ANDA Current 71205-080 Ramipril Ramipril Proficient Rx LP ANDA Current 71205-080 Ramipril Ramipril Proficient Rx LP ANDA Current 71335-0196 Ramipril Ramipril Bryant Ranch Prepack ANDA Current 71335-0894 Ramipril Ramipril Bryant Ranch Prepack ANDA Current 71335-0894 Ramipril Ramipril Bryant Ranch Prepack ANDA Current 71335-1056 Ramipril Ramipril Bryant Ranch Prepack ANDA Current 71335-1056 Ramipril Ramipril Bryant Ranch Prepack ANDA Current 71335-1057 Ramipril Ramipril Bryant Ranch Prepack ANDA Current 71335-1057 Ramipril Ramipril Bryant Ranch Prepack ANDA Current