Application 064022
- Type
- ANDA
- Sponsor
- TARO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NYSTATIN | NYSTATIN | CREAM;TOPICAL | 100,000 UNITS/GM | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064022-001 | NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM / TOPICAL | AT | RS | 1993-01-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A064022-001 | AT |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A064022-001 | NYSTATIN | 100,000 UNITS/GM | CREAM / TOPICAL | AT | RS | 1993-01-29 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A064022-001 | AT | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nystatin | NYSTATIN | Sun Pharmaceutical Industries, Inc. | 4d845b3f-ca26-4c47-b424-b6d783cc10e5 | 2025-07-03 | Adverse reactions | 064022 ANDA064022 51672-1289 |
| Nystatin | NYSTATIN | NuCare Pharmaceuticals,Inc. | cf6b7c68-7769-1808-e053-2995a90aa426 | 2025-02-10 | Adverse reactions | 064022 ANDA064022 68071-2556 |
| NYSTATIN | NYSTATIN | DIRECT RX | cd387929-5b72-e3c0-e053-2a95a90adb22 | 2025-01-20 | Adverse reactions | 064022 ANDA064022 72189-278 |
| Nystatin | NYSTATIN | NuCare Pharmaceuticals,Inc. | 57825c04-dcb5-b76d-e053-2991aa0a4c1d | 2024-08-14 | Adverse reactions | 064022 ANDA064022 66267-952 |
| Nystatin | NYSTATIN | Proficient Rx LP | 5ef15e1c-66dc-4858-8552-d83e42c3883e | 2019-11-01 | Adverse reactions | 064022 ANDA064022 63187-703 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-761 | Nystatin | Nystatin | Rebel Distributors Corp | ANDA | Current |
| 51672-1289 | Nystatin | Nystatin | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-1289 | Nystatin | Nystatin | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 63187-703 | Nystatin | Nystatin | Proficient Rx LP | ANDA | Current |
| 63187-703 | Nystatin | Nystatin | Proficient Rx LP | ANDA | Current |
| 66267-952 | Nystatin | Nystatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-952 | Nystatin | Nystatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2556 | Nystatin | Nystatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7366 | Nystatin | Nystatin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7949 | Nystatin | Nystatin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7949 | Nystatin | Nystatin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 72189-278 | NYSTATIN | NYSTATIN | DIRECT RX | ANDA | Current |
| 72189-278 | NYSTATIN | NYSTATIN | DIRECT RX | ANDA | Current |