Home Applications 074941 Application 074941
Type ANDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE INJECTABLE;INJECTION 5MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A074941-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 1998-04-15
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 · 43 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 2026-09-14 22:38:34 2026-08 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 1998-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 1998-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 1998-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 1998-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 f41ea6bd6efb…
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.
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 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-1171 Diltiazem Hydrochloride Diltiazem Hydrochloride Hospira, Inc. ANDA Current 0409-1171 Diltiazem Hydrochloride Diltiazem Hydrochloride Hospira, Inc. ANDA Current 0409-1171 Diltiazem Hydrochloride Diltiazem Hydrochloride Hospira, Inc. ANDA Current 0409-1171 Diltiazem Hydrochloride Diltiazem Hydrochloride Hospira, Inc. ANDA Current 0409-1171 Diltiazem Hydrochloride Diltiazem Hydrochloride Hospira, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42903 ORIG 2003-04-30 30720 ORIG 2003-04-30 18377 ORIG 2003-04-30