Home Applications 219073 Application 219073
Type ANDA
Sponsor UTOPIC PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 60MG No No 002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 90MG No No 003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219073-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 A219073-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 A219073-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
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 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 a50c72e98297…
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 6 of 6 · 109 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 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.