Home Applications 218032 Application 218032
Type ANDA
Sponsor NOVAST LABS 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 1 .
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 A218032-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 A218032-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 A218032-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02
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 2026-02-19 14:30 UTC 2026-02 A218032-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218032-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218032-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218032-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218032-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218032-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218032-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218032-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218032-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218032-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218032-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218032-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 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 1 of 1 · 1 matching rows.