Home Applications 203693 Application 203693
Type ANDA
Sponsor ACTAVIS LABS FL INC 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 43 .
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 A203693-001 NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 A203693-002 NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 A203693-003 NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16
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 4 · 129 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 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203693-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL 2017-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203693-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL 2017-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203693-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL 2017-10-16 301d65b070ca…
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 3 of 4 · 68 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NITROLINGUAL NITROGLYCERIN INDEPENDENCE PHARMACEUTICALS, LLC d19b5f51-ca85-48d6-9ccd-8ae26249cdc3 2024-05-13 Warnings, Adverse reactions Name fallback generic name: NITROGLYCERIN NITROGLYCERIN NITROGLYCERIN Cosette Pharmaceuticals, Inc. ac908e70-9425-4e9c-8c67-7b2882b40204 2024-02-21 Warnings, Adverse reactions Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN NITROGLYCERIN NITROGLYCERIN Proficient Rx LP 160b85ac-d964-463b-9f1e-1429f14ed318 2024-02-01 Warnings, Adverse reactions Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN Nitroglycerin NITROGLYCERIN Prasco Laboratories f9731c86-34b0-42a2-8b39-eca907e02e74 2024-01-01 Warnings, Adverse reactions Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN Nitroglycerin NITROGLYCERIN A-S Medication Solutions fc297c0a-a412-40be-8414-4bf9906fd300 2023-12-11 Warnings, Adverse reactions Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN Glonoinum NITROGLYCERIN Boiron 85a1163a-fe45-e31a-e053-2991aa0a6466 2023-11-13 Name fallback generic name: NITROGLYCERIN Glonoinum NITROGLYCERIN Boiron 85a39d5c-2b11-62ed-e053-2a91aa0a0a31 2023-11-13 Name fallback generic name: NITROGLYCERIN Glonoinum NITROGLYCERIN Boiron 85a33a5a-41c6-3d84-e053-2a91aa0a6ec7 2023-11-13 Name fallback generic name: NITROGLYCERIN Glonoinum NITROGLYCERIN Boiron 7c0efc90-7a53-11e6-a302-424c58303031 2023-11-13 Name fallback generic name: NITROGLYCERIN NITROGLYCERIN NITROGLYCERIN Aurobindo Pharma Limited 26c314ea-077e-490b-826b-2aafcb6e9564 2023-11-01 Warnings, Adverse reactions Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN Glonoinum NITROGLYCERIN Boiron 85a47cfa-4d34-a596-e053-2a91aa0a02dc 2023-10-30 Name fallback generic name: NITROGLYCERIN Glonoinum NITROGLYCERIN Boiron 85a3b808-b45a-f2f0-e053-2a91aa0af21f 2023-10-23 Name fallback generic name: NITROGLYCERIN NITROGLYCERIN NITROGLYCERIN Natco Pharma USA LLC 941ac242-120e-47c1-ac03-50026ff93dd6 2023-07-20 Warnings, Adverse reactions Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN Nitroglycerin NITROGLYCERIN Medical Purchasing Solutions, LLC 6671d89f-cc89-c03c-e053-2a91aa0aa5fa 2023-06-05 Warnings, Adverse reactions Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN Nitroglycerin NITROGLYCERIN Medical Purchasing Solutions, LLC 8959095a-8cd8-f7d4-e053-2995a90a6e8f 2023-05-31 Warnings, Adverse reactions Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN NITRO-DUR NITROGLYCERIN Ingenus Pharmaceuticals, LLC 5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0 2023-05-30 Boxed warning, Warnings, Adverse reactions Name fallback generic name: NITROGLYCERIN NITROGLYCERIN NITROGLYCERIN Medical Purchasing Solutions, LL f9b52553-5a26-d374-e053-6294a90a40c7 2023-04-19 Warnings, Adverse reactions Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN Glonoinum NITROGLYCERIN Boiron 85a3f76b-7b09-5d00-e053-2a91aa0ad1de 2023-02-20 Name fallback generic name: NITROGLYCERIN Nitrostat NITROGLYCERIN Viatris Specialty LLC 9a52da75-d0af-4237-96c0-0b12adfa8636 2023-02-15 Warnings, Adverse reactions Name fallback generic name: NITROGLYCERIN Glonoinum NITROGLYCERIN Boiron 85a39643-ae56-f21e-e053-2991aa0a4915 2023-01-23 Name fallback generic name: NITROGLYCERIN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.