Application 020145
- Type
- NDA
- Sponsor
- USPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITRO-DUR | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/HR | Yes | Yes |
| 002 | NITRO-DUR | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.2MG/HR | Yes | Yes |
| 003 | NITRO-DUR | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.3MG/HR | Yes | Yes |
| 004 | NITRO-DUR | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.4MG/HR | Yes | Yes |
| 005 | NITRO-DUR | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.6MG/HR | Yes | Yes |
| 006 | NITRO-DUR | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.8MG/HR | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020145-001 | NITRO-DUR | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1995-04-04 | |
| N020145-002 | NITRO-DUR | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1995-04-04 | |
| N020145-003 | NITRO-DUR | NITROGLYCERIN | 0.3MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1995-04-04 | |
| N020145-004 | NITRO-DUR | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | |
| N020145-005 | NITRO-DUR | NITROGLYCERIN | 0.6MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1995-04-04 | |
| N020145-006 | NITRO-DUR | NITROGLYCERIN | 0.8MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1995-04-04 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020145-001 | NITRO-DUR | 0.1MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1995-04-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020145-002 | NITRO-DUR | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1995-04-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020145-003 | NITRO-DUR | 0.3MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1995-04-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020145-004 | NITRO-DUR | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020145-005 | NITRO-DUR | 0.6MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1995-04-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020145-006 | NITRO-DUR | 0.8MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1995-04-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020145-001 | NITRO-DUR | 0.1MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020145-002 | NITRO-DUR | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020145-003 | NITRO-DUR | 0.3MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020145-004 | NITRO-DUR | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020145-005 | NITRO-DUR | 0.6MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020145-006 | NITRO-DUR | 0.8MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020145-001 | NITRO-DUR | 0.1MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020145-002 | NITRO-DUR | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020145-003 | NITRO-DUR | 0.3MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020145-004 | NITRO-DUR | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020145-005 | NITRO-DUR | 0.6MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020145-006 | NITRO-DUR | 0.8MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020145-001 | NITRO-DUR | 0.1MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020145-002 | NITRO-DUR | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020145-003 | NITRO-DUR | 0.3MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020145-004 | NITRO-DUR | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020145-005 | NITRO-DUR | 0.6MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020145-006 | NITRO-DUR | 0.8MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020145-001 | NITRO-DUR | 0.1MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020145-002 | NITRO-DUR | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020145-003 | NITRO-DUR | 0.3MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020145-004 | NITRO-DUR | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020145-005 | NITRO-DUR | 0.6MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020145-006 | NITRO-DUR | 0.8MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020145-001 | NITRO-DUR | 0.1MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020145-002 | NITRO-DUR | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020145-003 | NITRO-DUR | 0.3MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020145-004 | NITRO-DUR | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020145-005 | NITRO-DUR | 0.6MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020145-006 | NITRO-DUR | 0.8MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020145-001 | NITRO-DUR | 0.1MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020145-002 | NITRO-DUR | 0.2MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020145-003 | NITRO-DUR | 0.3MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020145-004 | NITRO-DUR | 0.4MG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1995-04-04 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020145-001 | BX | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020145-002 | BX | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020145-004 | BX | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020145-005 | BX | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020145-001 | BX | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020145-002 | BX | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020145-004 | BX | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020145-005 | BX | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020145-001 | BX | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020145-002 | BX | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020145-004 | BX | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020145-005 | BX | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020145-001 | BX | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020145-002 | BX | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020145-004 | BX | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020145-005 | BX | 1 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| NITRO-DUR | NITROGLYCERIN | Ingenus Pharmaceuticals, LLC | 5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0 | 2023-05-30 | Boxed warning, Warnings, Adverse reactions | 020145 NDA020145 50742-516 50742-517 50742-513 50742-514 50742-518 50742-515 |
| Nitroglycerin Transdermal Infusion System | NITROGLYCERIN | Dr. Reddy's Laboratories, Inc. | 4f85d2e0-2e37-fcd1-276d-5a6466554289 | 2020-02-26 | Boxed warning, Warnings, Adverse reactions | 020145 NDA020145 43598-896 43598-894 43598-895 43598-893 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43598-893 | Nitroglycerin Transdermal Infusion System | Nitroglycerin | Dr. Reddy's Laboratories, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43598-893 | Nitroglycerin Transdermal Infusion System | Nitroglycerin | Dr. Reddy's Laboratories, Inc. | NDA | Current |
| 43598-894 | Nitroglycerin Transdermal Infusion System | Nitroglycerin | Dr. Reddy's Laboratories, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43598-894 | Nitroglycerin Transdermal Infusion System | Nitroglycerin | Dr. Reddy's Laboratories, Inc. | NDA | Current |
| 43598-895 | Nitroglycerin Transdermal Infusion System | Nitroglycerin | Dr. Reddy's Laboratories, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43598-895 | Nitroglycerin Transdermal Infusion System | Nitroglycerin | Dr. Reddy's Laboratories, Inc. | NDA | Current |
| 43598-896 | Nitroglycerin Transdermal Infusion System | Nitroglycerin | Dr. Reddy's Laboratories, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43598-896 | Nitroglycerin Transdermal Infusion System | Nitroglycerin | Dr. Reddy's Laboratories, Inc. | NDA | Current |
| 50742-513 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-513 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-513 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-514 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-514 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-514 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-515 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-515 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-515 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-516 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-516 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-516 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-517 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-517 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-517 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-518 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-518 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-518 | NITRO-DUR | nitroglycerin | Ingenus Pharmaceuticals, LLC | NDA | Current |