Home Applications 020240 Application 020240
Type NDA
Sponsor SCHERING Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RENORMAX SPIRAPRIL HYDROCHLORIDE TABLET;ORAL 3MG No No 002 RENORMAX SPIRAPRIL HYDROCHLORIDE TABLET;ORAL 6MG No No 003 RENORMAX SPIRAPRIL HYDROCHLORIDE TABLET;ORAL 12MG No No 004 RENORMAX SPIRAPRIL HYDROCHLORIDE TABLET;ORAL 24MG 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 N020240-001 RENORMAX SPIRAPRIL HYDROCHLORIDE 3MG TABLET / ORAL 1994-12-29 N020240-002 RENORMAX SPIRAPRIL HYDROCHLORIDE 6MG TABLET / ORAL 1994-12-29 N020240-003 RENORMAX SPIRAPRIL HYDROCHLORIDE 12MG TABLET / ORAL 1994-12-29 N020240-004 RENORMAX SPIRAPRIL HYDROCHLORIDE 24MG TABLET / ORAL 1994-12-29
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 2 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 2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020240-001 RENORMAX 3MG TABLET / ORAL 1994-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020240-002 RENORMAX 6MG TABLET / ORAL 1994-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020240-003 RENORMAX 12MG TABLET / ORAL 1994-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020240-004 RENORMAX 24MG TABLET / ORAL 1994-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020240-001 RENORMAX 3MG TABLET / ORAL 1994-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020240-002 RENORMAX 6MG TABLET / ORAL 1994-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020240-003 RENORMAX 12MG TABLET / ORAL 1994-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020240-004 RENORMAX 24MG TABLET / ORAL 1994-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020240-001 RENORMAX 3MG TABLET / ORAL 1994-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020240-002 RENORMAX 6MG TABLET / ORAL 1994-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020240-003 RENORMAX 12MG TABLET / ORAL 1994-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020240-004 RENORMAX 24MG TABLET / ORAL 1994-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020240-001 RENORMAX 3MG TABLET / ORAL 1994-12-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020240-002 RENORMAX 6MG TABLET / ORAL 1994-12-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020240-003 RENORMAX 12MG TABLET / ORAL 1994-12-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020240-004 RENORMAX 24MG TABLET / ORAL 1994-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020240-001 RENORMAX 3MG TABLET / ORAL 1994-12-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020240-002 RENORMAX 6MG TABLET / ORAL 1994-12-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020240-003 RENORMAX 12MG TABLET / ORAL 1994-12-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020240-004 RENORMAX 24MG TABLET / ORAL 1994-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020240-001 RENORMAX 3MG TABLET / ORAL 1994-12-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020240-002 RENORMAX 6MG TABLET / ORAL 1994-12-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020240-003 RENORMAX 12MG TABLET / ORAL 1994-12-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020240-004 RENORMAX 24MG TABLET / ORAL 1994-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020240-001 RENORMAX 3MG TABLET / ORAL 1994-12-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020240-002 RENORMAX 6MG TABLET / ORAL 1994-12-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020240-003 RENORMAX 12MG TABLET / ORAL 1994-12-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020240-004 RENORMAX 24MG TABLET / ORAL 1994-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020240-001 RENORMAX 3MG TABLET / ORAL 1994-12-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020240-002 RENORMAX 6MG TABLET / ORAL 1994-12-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020240-003 RENORMAX 12MG TABLET / ORAL 1994-12-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020240-004 RENORMAX 24MG TABLET / ORAL 1994-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020240-001 RENORMAX 3MG TABLET / ORAL 1994-12-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020240-002 RENORMAX 6MG TABLET / ORAL 1994-12-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020240-003 RENORMAX 12MG TABLET / ORAL 1994-12-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020240-004 RENORMAX 24MG TABLET / ORAL 1994-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020240-001 RENORMAX 3MG TABLET / ORAL 1994-12-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020240-002 RENORMAX 6MG TABLET / ORAL 1994-12-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020240-003 RENORMAX 12MG TABLET / ORAL 1994-12-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020240-004 RENORMAX 24MG TABLET / ORAL 1994-12-29 4b0b4de00fa7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.