Application 062876
- Type
- ANDA
- Sponsor
- TARO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NYSTATIN | NYSTATIN | SUSPENSION;ORAL | 100,000 UNITS/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062876-001 | NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1988-02-29 |
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 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1988-02-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1988-02-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1988-02-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1988-02-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A062876-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1988-02-29 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A062876-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062876-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062876-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062876-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062876-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062876-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062876-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062876-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062876-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062876-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062876-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062876-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062876-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062876-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062876-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062876-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062876-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062876-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062876-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062876-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A062876-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062876-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062876-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062876-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062876-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062876-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A062876-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A062876-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062876-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062876-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062876-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062876-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A062876-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A062876-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062876-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A062876-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A062876-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A062876-001 | AA | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Nystatin | NYSTATIN | RedPharm Drug, Inc | f4c298d5-b012-7b56-e053-2a95a90a3d55 | 2026-01-24 | Adverse reactions | Nystatin NYSTATIN |
| NYSTATIN | NYSTATIN | ATLANTIC BIOLOGICALS CORP. | 5c08148f-83e5-4f14-b0d3-af8d2c26062e | 2026-01-13 | Adverse reactions | NYSTATIN NYSTATIN |
| Nystatin | NYSTATIN | Chartwell RX, LLC | 30175930-f5fa-403d-a3ac-3bdbbe723641 | 2025-12-17 | Adverse reactions | Nystatin NYSTATIN |
| NYSTATIN | NYSTATIN | Kesin Pharma Corporation | 43817169-bbe8-58ee-e063-6294a90a1250 | 2025-12-11 | Adverse reactions | NYSTATIN NYSTATIN |
| Nystatin | NYSTATIN | Chartwell Governmental & Specialty RX, LLC | 88a0a22e-8d6b-42aa-b225-2d57fb5b3a97 | 2025-11-12 | Adverse reactions | Nystatin NYSTATIN |
| Nystatin | NYSTATIN CREAM | NuCare Pharmaceuticals, Inc. | 42f21220-c68a-d748-e063-6394a90a1e2f | 2025-11-06 | Adverse reactions | Nystatin |
| Nystatin | NYSTATIN | Bryant Ranch Prepack | b71356cf-7b6e-4ca0-9571-c80fd0d846cb | 2025-10-23 | Adverse reactions | Nystatin NYSTATIN |
| Nystatin | NYSTATIN | Cardinal Health 107, LLC | 56aca0e2-8691-4701-beba-e2315524709f | 2025-10-23 | Adverse reactions | Nystatin NYSTATIN |
| Nystop | NYSTATIN | Bryant Ranch Prepack | 64041bdf-1207-47f6-93f3-bc4656a7d2ae | 2025-10-21 | Adverse reactions | NYSTATIN |
| Nystop | NYSTATIN | Bryant Ranch Prepack | affea013-4f09-4e7d-a696-9f501d379af6 | 2025-10-21 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Bryant Ranch Prepack | b6aa24e6-1acb-4fd3-9ec7-11b1a69c1598 | 2025-10-08 | Adverse reactions | Nystatin NYSTATIN |
| Nystatin | NYSTATIN | Northstar Rx LLC | 9e6d0b0d-a68f-46aa-a707-3110ecb931b4 | 2025-09-30 | Adverse reactions | Nystatin NYSTATIN |
| Nystatin | NYSTATIN | Bryant Ranch Prepack | 840eebe8-5de2-40c5-acfd-03a98b2e790e | 2025-09-23 | Adverse reactions | Nystatin NYSTATIN |
| Nystatin | NYSTATIN | AvKARE | 8fd35f97-5405-2160-ca0f-35034ecd5a92 | 2025-09-18 | Adverse reactions | Nystatin NYSTATIN |
| NYSTATIN | NYSTATIN | Kanchan Healthcare Inc | 90a52c3f-3ef7-4f3b-9fe5-40af408e9f2a | 2025-09-12 | Adverse reactions | NYSTATIN NYSTATIN |
| Nystop | NYSTATIN | Bryant Ranch Prepack | 69ebb4dd-f45d-448d-97cd-3f8935493975 | 2025-08-26 | Adverse reactions | NYSTATIN |
| nystatin | NYSTATIN | Bryant Ranch Prepack | a5711dbe-f71c-435c-91f2-38c357532d18 | 2025-08-19 | Adverse reactions | nystatin NYSTATIN |
| Nyamyc | NYSTATIN | Upsher-Smith Laboratories, LLC | 01b44f91-9b68-464a-9693-b5d3e793bf3c | 2025-07-09 | Adverse reactions | NYSTATIN |
| Nystatin | NYSTATIN | Sun Pharmaceutical Industries, Inc. | 4d845b3f-ca26-4c47-b424-b6d783cc10e5 | 2025-07-03 | Adverse reactions | Nystatin NYSTATIN |
| nystatin | NYSTATIN | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | e87b8480-987d-4f82-87bf-cf831d6984a1 | 2025-06-23 | Adverse reactions | nystatin NYSTATIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-2937 | Nystatin | Nystatin | A-S Medication Solutions | ANDA | Current |
| 51672-4117 | Nystatin | Nystatin | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4117 | Nystatin | Nystatin | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 70166-331 | Nystatin | Nystatin | Lohxa | ANDA | Current |