Application 206289
- Type
- NDA
- Sponsor
- AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION/DROPS;OPHTHALMIC | 1% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N206289-001 | ATROPINE SULFATE | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N206289-001 | AT1 |
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 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT1 | RLD | 2014-07-18 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2014-07-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2014-07-18 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2014-07-18 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2014-07-18 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2014-07-18 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2014-07-18 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2014-07-18 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2014-07-18 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD | 2014-07-18 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD | 2014-07-18 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD | 2014-07-18 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD | 2014-07-18 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD | 2014-07-18 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N206289-001 | ATROPINE SULFATE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2014-07-18 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N206289-001 | AT1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206289-001 | AT1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N206289-001 | AT1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206289-001 | AT1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206289-001 | AT1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206289-001 | AT1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206289-001 | AT1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N206289-001 | AT1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N206289-001 | AT1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N206289-001 | AT1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N206289-001 | AT1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N206289-001 | AT1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N206289-001 | AT1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N206289-001 | AT1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N206289-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N206289-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N206289-001 | AT | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N206289-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N206289-001 | AT | 1 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N206289-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N206289-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N206289-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N206289-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N206289-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N206289-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N206289-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N206289-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N206289-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N206289-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N206289-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N206289-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N206289-001 | AT | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N206289-001 | AT1 | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Atropine | ATROPINE SULFATE | Gland Pharma Limited | a116af5c-ba4c-408c-9a02-4bc33772aa8d | 2026-08-03 | Warnings, Adverse reactions | ATROPINE SULFATE |
| Atropine Sulfate | ATROPINE SULFATE | Henry Schein, Inc. | 0f5b0961-efe7-42c3-898e-2f7fc7fc90b1 | 2026-07-28 | Warnings, Adverse reactions | Atropine Sulfate ATROPINE SULFATE |
| ATROPINE SULFATE | ATROPINE SULFATE | HF Acquisition Co LLC, DBA HealthFirst | 768dc21a-b7d9-144c-e053-2991aa0af889 | 2026-06-19 | Warnings, Adverse reactions | ATROPINE SULFATE ATROPINE SULFATE |
| Atropine Sulfate | ATROPINE SULFATE | Hospira, Inc. | ad8916e7-206e-409e-2582-30d072845dd4 | 2026-05-18 | Warnings, Adverse reactions | Atropine Sulfate ATROPINE SULFATE |
| Atropine sulfate | ATROPINE SULFATE | Edenbridge Pharmaceuticals LLC. | b39f5876-5d6f-4a8f-bd24-bd4be24ff568 | 2026-05-07 | Warnings, Adverse reactions | Atropine sulfate ATROPINE SULFATE |
| Atropine Sulfate | ATROPINE SULFATE | REMEDYREPACK INC. | 46ba6000-b842-449a-8dd4-7bb9dc7a74c5 | 2026-04-03 | Warnings, Adverse reactions | Atropine Sulfate ATROPINE SULFATE |
| atropine sulfate | ATROPINE SULFATE | Alcon Laboratories, Inc. | c8093125-ed1a-4eb6-9c81-52c5c7376481 | 2026-03-13 | Warnings, Adverse reactions | atropine sulfate ATROPINE SULFATE |
| Atropine | ATROPINE SULFATE | Apotex Corp. | 127a7e32-a150-01d6-a66a-b7708d85809f | 2026-03-10 | Warnings, Adverse reactions | ATROPINE SULFATE |
| Atropine Sulfate | ATROPINE SULFATE | A-S Medication Solutions | 739f384f-1a69-4953-93a0-aa6a76de0ecc | 2026-02-18 | Warnings, Adverse reactions | Atropine Sulfate ATROPINE SULFATE |
| ATROPINE | ATROPINE SULFATE | A-S Medication Solutions | b4736dbc-b7c8-4b33-b7a8-a47c5654a127 | 2026-02-10 | Warnings, Adverse reactions | ATROPINE SULFATE |
| Atropine Sulfate | ATROPINE SULFATE | Bausch & Lomb Americas Inc. | e294ce2b-6bb5-4f84-8a6d-ce2402ed926d | 2026-02-07 | Warnings, Adverse reactions | Atropine Sulfate ATROPINE SULFATE |
| Atropine | ATROPINE SULFATE | Redpharm Drug | 46e98d0b-3a04-7feb-e063-6394a90ac75e | 2025-12-27 | Warnings, Adverse reactions | ATROPINE SULFATE |
| Atropine Sulfate | ATROPINE SULFATE | Redpharm Drug | 301ea0f4-a1dc-ad4f-e063-6294a90acc1c | 2025-12-23 | Warnings, Adverse reactions | Atropine Sulfate ATROPINE SULFATE |
| Atropine Sulfate | ATROPINE SULFATE INJECTION | Medefil, Inc. | fbfdf718-befe-ad22-e053-6294a90a3715 | 2025-12-23 | Warnings, Adverse reactions | Atropine Sulfate |
| Atropine Sulfate | ATROPINE SULFATE | ProPharma Distribution | 38404931-980b-0019-e063-6394a90a933f | 2025-12-18 | Warnings, Adverse reactions | Atropine Sulfate ATROPINE SULFATE |
| Atropine Sulfate | ATROPINE SULFATE | ProPharma Distribution | 3d5c747f-3bf7-2597-e063-6394a90a828c | 2025-12-18 | Warnings, Adverse reactions | Atropine Sulfate ATROPINE SULFATE |
| Atropine | ATROPINE SULFATE | Amneal Pharmaceuticals NY LLC | f8718be5-8fa4-4c36-a4fd-fac7c3953f5a | 2025-12-04 | Warnings, Adverse reactions | ATROPINE SULFATE |
| atropine sulfate | ATROPINE SULFATE | Amneal Pharmaceuticals LLC | 80a31286-a741-4440-b200-290c08925d06 | 2025-12-01 | Warnings, Adverse reactions | atropine sulfate ATROPINE SULFATE |
| Atropine Sulfate | ATROPINE SULFATE | NorthStar RxLLC | f750135c-e6bf-4aa7-a343-87b1204df94f | 2025-11-12 | Warnings, Adverse reactions | Atropine Sulfate ATROPINE SULFATE |
| Atropine Sulfate | ATROPINE SULFATE MONOHYDRATE | Medical Purchasing Solutions, LLC | 423fc064-57cb-8308-e063-6394a90a2617 | 2025-10-28 | Warnings, Adverse reactions | Atropine Sulfate |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13985-606 | Atropine | Atropine Sulfate | MWI | NDA | Current |
| 13985-606 | Atropine | Atropine Sulfate | MWI | NDA | Current |
| 13985-606 | Atropine | Atropine Sulfate | MWI | NDA | Current |
| 13985-606 | Atropine | Atropine Sulfate | MWI | NDA | Current |
| 17478-215 | Atropine | Atropine Sulfate | Akorn, Inc. | NDA | Current |
| 17478-215 | Atropine | Atropine Sulfate | Akorn | NDA | Current |
| 17478-215 | Atropine | Atropine Sulfate | Akorn | NDA | Current |
| 17478-215 | Atropine | Atropine Sulfate | Akorn, Inc. | NDA | Current |
| 17478-215 | Atropine | Atropine Sulfate | Akorn | NDA | Current |
| 50090-3104 | Atropine | Atropine Sulfate | A-S Medication Solutions | NDA | Current |
| 50090-3104 | Atropine | Atropine Sulfate | A-S Medication Solutions | NDA | Current |
| 50090-6295 | Atropine | Atropine Sulfate | A-S Medication Solutions | NDA | Current |
| 76478-015 | Atropine | Atropine Sulfate | Akorn | NDA | Current |
| 76478-015 | Atropine | Atropine Sulfate | Akorn | NDA | Current |
| 76478-015 | Atropine | Atropine Sulfate | Akorn | NDA | Current |