Home Applications 075086 Application 075086
Type ANDA
Sponsor AKORN INC 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 A075086-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075086-001 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 · 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 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075086-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-09 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 6 of 6 · 111 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diltiazem Hydrochloride Extended-Release DILTIAZEM HYDROCHLORIDE Bryant Ranch Prepack 2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6 2024-01-10 Warnings, Adverse reactions Name fallback generic name: DILTIAZEM HYDROCHLORIDE Diltiazem Hydrochloride Extended-Release DILTIAZEM HYDROCHLORIDE Bryant Ranch Prepack 762c3007-b22f-4d35-87b4-191fec8b3a9a 2023-11-20 Warnings, Adverse reactions Name fallback generic name: DILTIAZEM HYDROCHLORIDE Diltiazem Hydrochloride Extended-Release DILTIAZEM HYDROCHLORIDE Bryant Ranch Prepack eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4 2023-11-20 Warnings, Adverse reactions Name fallback generic name: DILTIAZEM HYDROCHLORIDE Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE Sun Pharmaceutical Industries, Inc. eebf29fe-ce22-4482-b850-5854550bf2c4 2023-08-04 Warnings, Adverse reactions Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE Bryant Ranch Prepack 225a87fb-d353-4ee7-bd08-14d631ff6b16 2023-06-07 Warnings, Adverse reactions Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE Medical Purchasing Solutions, LLC 9f69371d-3ede-285d-e053-2a95a90a6e42 2023-05-30 Warnings, Adverse reactions Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE Proficient Rx LP a24255a3-88b1-47ef-90fc-51619a1c5a63 2023-05-01 Warnings, Adverse reactions Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE Diltiazem hydrochloride DILTIAZEM HYDROCHLORIDE A-S Medication Solutions 5460158f-7782-45f4-89b1-f84e6ba178d8 2023-01-17 Warnings, Adverse reactions Name fallback brand name: Diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE Sun Pharmaceutical Industries, Inc. 6f71ba5e-7bd6-409a-80c6-2f22d975aefc 2023-01-09 Warnings, Adverse reactions Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE Oceanside Pharmaceuticals f6a24de7-8ffe-48af-873f-10fdcd5551d1 2020-06-02 Warnings, Adverse reactions Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE Bryant Ranch Prepack 609e97e5-ebc7-4268-84ea-f279284c89e2 2020-01-19 Warnings, Adverse reactions Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-817 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn, Inc. ANDA Current 17478-837 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn, Inc. ANDA Current 17478-837 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn, Inc. ANDA Current 17478-837 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn, Inc. ANDA Current 17478-837 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn ANDA Current 17478-937 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn ANDA Current 17478-937 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn, Inc. ANDA Current 17478-937 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn, Inc. ANDA Current 17478-937 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn ANDA Current 17478-937 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn ANDA Current 17478-937 Diltiazem Hydrochloride Diltiazem Hydrochloride Akorn, Inc. ANDA Current 71872-7062 Diltiazem Hydrochloride Diltiazem Hydrochloride Medical Purchasing Solutions, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 18386 ORIG 2004-06-02 8516 ORIG 2004-06-02 42931 ORIG 1998-04-09