Application 050619
- Type
- NDA
- Sponsor
- DELCOR ASSET CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MYCOSTATIN | NYSTATIN | PASTILLE;ORAL | 200,000 UNITS | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050619-001 | MYCOSTATIN | NYSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050619-001 | MYCOSTATIN | 200,000 UNITS | PASTILLE / ORAL | 1987-04-09 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Nystop | NYSTATIN | Bryant Ranch Prepack | 5bce98a3-2964-4edc-b8da-8a46dafadf5e | 2024-01-11 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Proficient Rx LP | 8566c432-741f-4af7-91d7-1b7668ce5e95 | 2023-12-01 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | A-S Medication Solutions | 6a3bb3da-adf9-46d2-a5ff-f796e7aae7a1 | 2023-11-24 | Adverse reactions | NYSTATIN |
| NYSTATIN | NYSTATIN | Zydus Pharmaceuticals USA Inc. | 2daf159d-6a12-4b5d-97b3-8069c17e7635 | 2023-11-04 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Actavis Pharma, Inc. | aee7ce4c-8cc6-4446-a4d7-63bc4773066f | 2023-10-30 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | A-S Medication Solutions | cc3516cd-985c-489f-b4a1-8477876c5a97 | 2023-10-19 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Bryant Ranch Prepack | 53d1c23b-9cf2-4941-8701-8a7da1b066cc | 2023-03-03 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Bryant Ranch Prepack | 84383bc5-1282-43d6-9303-23c8fd8d075f | 2023-03-03 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | A-S Medication Solutions | e069d495-7f1a-4970-8f4d-aa93d124b3fc | 2023-02-04 | Adverse reactions | NYSTATIN |
| NYSTATIN | NYSTATIN | Bryant Ranch Prepack | b06c65cd-5b65-4bc6-aae9-b9381c6f1948 | 2023-01-26 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Teva Pharmaceuticals USA, Inc. | f03b294d-10cd-4bba-92c8-42ae9b110cd0 | 2022-11-01 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Viona Pharmaceuticals Inc | e135a7d2-adba-48a2-b3e1-07b778cce9b0 | 2022-10-08 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Proficient Rx LP | d7d04c02-d07d-4382-8f93-5c0c3e68790c | 2022-10-01 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Proficient Rx LP | e7f0e152-233a-492e-a297-7bf2c543c113 | 2022-05-02 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Pharmaceutical Associates, Inc. | 31e3da10-5a7b-4bc5-8a4f-3e786b64c13a | 2022-01-13 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Macleods Pharmaceuticals Limited | d8ebb61a-a326-4f0d-a346-c3db045c3fb0 | 2021-08-25 | Adverse reactions | NYSTATIN |
| nystatin | NYSTATIN | Proficient Rx LP | 04d795f3-aad7-4b79-8ebc-43c500afe39b | 2021-08-01 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Macleods Pharmaceuticals Limited | fe3db8b2-9de4-4f9e-b763-8536a1e4cea8 | 2021-01-29 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Proficient Rx LP | 5ef15e1c-66dc-4858-8552-d83e42c3883e | 2019-11-01 | Adverse reactions | NYSTATIN |
| NYSTATIN | NYSTATIN | Leading Pharma, LLC | 8900ba02-2c6a-4dd4-b82f-45620c06e255 | 2019-09-19 | Adverse reactions | NYSTATIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 7892 | SUPPL | 2003-05-29 |