Home Applications 075578 Application 075578
Type ANDA
Sponsor DR REDDYS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENALAPRILAT ENALAPRILAT INJECTABLE;INJECTION 1.25MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075578-001 ENALAPRILAT ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075578-001 AP
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 2 · 42 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 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 e64feba35796…
Observed Orange Book normalized TE history# 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 Enalaprilat ENALAPRILAT Dr. Reddys Laboratories Inc 5d398da1-020c-ccb1-a775-ce8e0b29d621 2024-06-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075578 application number: ANDA075578
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0703-8401 Enalaprilat Enalaprilat Teva Parenteral Medicines, Inc. ANDA Current 0703-8411 Enalaprilat Enalaprilat Teva Parenteral Medicines, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8721 ORIG 2004-06-03 30944 ORIG 2000-08-22