Home Applications 217879 Application 217879
Type ANDA
Sponsor AUROBINDO PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NITROGLYCERIN NITROGLYCERIN TABLET;SUBLINGUAL 0.3MG No No 002 NITROGLYCERIN NITROGLYCERIN TABLET;SUBLINGUAL 0.4MG No No 003 NITROGLYCERIN NITROGLYCERIN TABLET;SUBLINGUAL 0.6MG 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 A217879-001 NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 A217879-002 NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 A217879-003 NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26
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.
Product history page 1 of 2 · 57 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 2026-02-19 14:30 UTC 2026-02 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 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 1 of 1 · 1 matching rows.