Application 075115
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITROGLYCERIN | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.2MG/HR | No | No |
| 002 | NITROGLYCERIN | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.4MG/HR | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075115-001 | NITROGLYCERIN | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | ||
| A075115-002 | NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 |
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 | 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 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075115-001 | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075115-002 | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2004-08-10 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NITROGLYCERIN | NITROGLYCERIN | HF Acquisition Co LLC, DBA HealthFirst | 7da79fdf-0969-1ddd-e053-2991aa0a3ec4 | 2022-12-09 | Warnings, Adverse reactions | NITROGLYCERIN NITROGLYCERIN |
| nitroglycerin lingual | NITROGLYCERIN | Padagis Israel Pharmaceuticals Ltd | e7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d | 2022-09-01 | Warnings, Adverse reactions | NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | Proficient Rx LP | 67a15ee9-a6ae-4a60-8333-e06c608cfd71 | 2022-07-01 | Warnings, Adverse reactions | Nitroglycerin NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | American Regent, Inc. | 8c52cdf6-87be-4719-b105-f08be096d462 | 2021-07-22 | Warnings, Adverse reactions | Nitroglycerin NITROGLYCERIN |
| Nitroglycerin Transdermal Infusion System | NITROGLYCERIN | Dr. Reddy's Laboratories, Inc. | 4f85d2e0-2e37-fcd1-276d-5a6466554289 | 2020-02-26 | Boxed warning, Warnings, Adverse reactions | NITROGLYCERIN |
| Nitrostat | NITROGLYCERIN | Proficient Rx LP | 6fe3965f-0dd8-4bae-9771-de25074cb1b0 | 2019-11-01 | Warnings, Adverse reactions | NITROGLYCERIN |
| Nitroglycerin In Dextrose | NITROGLYCERIN | Baxter Healthcare Company | 457a026c-ebce-4701-9deb-2d7652759a99 | 2016-08-22 | Warnings, Adverse reactions | NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | Mylan Pharmaceuticals Inc. | e98a2692-1cb9-4994-98d8-1d8d9ef1a256 | 2014-11-03 | Warnings, Adverse reactions | Nitroglycerin NITROGLYCERIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.