Application 019949
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIFLUCAN | FLUCONAZOLE | TABLET;ORAL | 50MG | Yes | No |
| 002 | DIFLUCAN | FLUCONAZOLE | TABLET;ORAL | 100MG | Yes | No |
| 003 | DIFLUCAN | FLUCONAZOLE | TABLET;ORAL | 200MG | Yes | Yes |
| 004 | DIFLUCAN | FLUCONAZOLE | TABLET;ORAL | 150MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019949-001 | DIFLUCAN | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 |
| N019949-002 | DIFLUCAN | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 |
| N019949-003 | DIFLUCAN | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 |
| N019949-004 | DIFLUCAN | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019949-001 | AB |
| N019949-002 | AB |
| N019949-003 | AB |
| N019949-004 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019949-001 | DIFLUCAN | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019949-002 | DIFLUCAN | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019949-003 | DIFLUCAN | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019949-004 | DIFLUCAN | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019949-001 | DIFLUCAN | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019949-002 | DIFLUCAN | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019949-003 | DIFLUCAN | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019949-004 | DIFLUCAN | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019949-001 | DIFLUCAN | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019949-002 | DIFLUCAN | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019949-003 | DIFLUCAN | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019949-004 | DIFLUCAN | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019949-001 | DIFLUCAN | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019949-002 | DIFLUCAN | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019949-003 | DIFLUCAN | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019949-004 | DIFLUCAN | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019949-001 | DIFLUCAN | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019949-002 | DIFLUCAN | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019949-003 | DIFLUCAN | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019949-004 | DIFLUCAN | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019949-001 | DIFLUCAN | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019949-002 | DIFLUCAN | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019949-003 | DIFLUCAN | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019949-004 | DIFLUCAN | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019949-001 | DIFLUCAN | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019949-002 | DIFLUCAN | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019949-003 | DIFLUCAN | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019949-004 | DIFLUCAN | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019949-001 | DIFLUCAN | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019949-002 | DIFLUCAN | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019949-003 | DIFLUCAN | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019949-004 | DIFLUCAN | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019949-001 | DIFLUCAN | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019949-002 | DIFLUCAN | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019949-003 | DIFLUCAN | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019949-004 | DIFLUCAN | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019949-001 | DIFLUCAN | 50MG | TABLET / ORAL | AB | RLD | 1990-01-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019949-002 | DIFLUCAN | 100MG | TABLET / ORAL | AB | RLD | 1990-01-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019949-003 | DIFLUCAN | 200MG | TABLET / ORAL | AB | RLD, RS | 1990-01-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019949-004 | DIFLUCAN | 150MG | TABLET / ORAL | AB | RLD | 1994-06-30 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019949-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019949-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019949-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019949-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019949-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019949-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019949-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019949-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019949-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019949-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019949-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019949-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019949-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019949-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019949-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019949-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019949-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019949-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019949-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019949-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019949-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019949-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019949-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019949-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019949-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019949-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019949-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019949-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019949-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019949-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019949-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019949-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019949-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019949-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019949-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019949-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019949-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019949-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019949-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019949-004 | AB | 1 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Fluconazole | FLUCONAZOLE | Mylan Pharmaceuticals Inc. | 737e0fac-a2d2-4053-a0d7-edbfb6248f69 | 2026-04-02 | Warnings, Adverse reactions | 59762-5015 59762-5016 59762-5017 59762-5018 |
| Diflucan | FLUCONAZOLE | Roerig | f694c617-3383-416c-91b6-b94fda371204 | 2026-04-02 | Warnings, Adverse reactions | 0049-3420 0049-3500 0049-3410 0049-3430 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0049-3410 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3410 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3410 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3410 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3410 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3410 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3410 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3410 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3410 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3420 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3420 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3420 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3420 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3420 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3420 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3420 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3420 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3420 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3430 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3430 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3430 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3430 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3430 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3430 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3430 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3430 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3430 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3500 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3500 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3500 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3500 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3500 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3500 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3500 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3500 | Diflucan | fluconazole | Roerig | NDA | Current |
| 0049-3500 | Diflucan | fluconazole | Roerig | NDA | Current |
| 50436-5128 | Fluconazole | fluconazole | Unit Dose Services | NDA AUTHORIZED GENERIC | Current |
| 55289-148 | Diflucan | fluconazole | PD-Rx Pharmaceuticals, In | NDA | Current |
| 55289-148 | Diflucan | fluconazole | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-148 | Diflucan | fluconazole | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-148 | Diflucan | fluconazole | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-148 | Diflucan | fluconazole | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-148 | Diflucan | fluconazole | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-148 | Diflucan | fluconazole | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-148 | Diflucan | fluconazole | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 59762-5015 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5015 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5015 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED | Current |
| 59762-5015 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5015 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5015 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5015 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5015 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5016 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5016 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5016 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED | Current |
| 59762-5016 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5016 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5016 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5016 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5016 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5017 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5017 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5017 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED | Current |
| 59762-5017 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5017 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5017 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5017 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5017 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5018 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5018 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5018 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED | Current |
| 59762-5018 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5018 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5018 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5018 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5018 | Fluconazole | fluconazole | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 69189-5016 | Fluconazole | fluconazole | Avera McKennan Hospital | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77483 | SUPPL | 2024-02-13 |
| 77479 | SUPPL | 2024-02-13 |
| 74760 | SUPPL | 2023-07-14 |
| 74749 | SUPPL | 2023-07-13 |
| 73245 | SUPPL | 2023-01-18 |
| 73241 | SUPPL | 2023-01-18 |
| 70511 | SUPPL | 2022-03-15 |
| 70474 | SUPPL | 2022-03-10 |
| 69137 | SUPPL | 2021-10-27 |
| 69118 | SUPPL | 2021-10-26 |
| 64537 | SUPPL | 2020-09-10 |
| 64532 | SUPPL | 2020-09-09 |
| 57710 | SUPPL | 2019-02-20 |
| 57502 | SUPPL | 2019-02-12 |
| 52993 | SUPPL | 2018-03-15 |
| 52924 | SUPPL | 2018-03-13 |
| 51873 | SUPPL | 2018-01-26 |
| 51466 | SUPPL | 2018-01-23 |
| 50241 | SUPPL | 2017-10-31 |
| 50235 | SUPPL | 2017-10-30 |
| 34124 | SUPPL | 2014-11-04 |
| 19873 | SUPPL | 2014-10-31 |
| 12087 | SUPPL | 2014-03-25 |
| 1837 | SUPPL | 2014-03-25 |
| 12086 | SUPPL | 2013-09-17 |
| 1836 | SUPPL | 2013-09-17 |
| 34123 | SUPPL | 2011-11-21 |
| 19872 | SUPPL | 2011-11-21 |
| 19871 | SUPPL | 2011-06-08 |
| 34122 | SUPPL | 2011-06-06 |
| 12085 | SUPPL | 2011-04-29 |
| 1835 | SUPPL | 2011-04-29 |
| 19870 | SUPPL | 2010-08-10 |
| 12084 | SUPPL | 2010-08-10 |
| 34121 | SUPPL | 2008-04-16 |
| 19869 | SUPPL | 2008-04-04 |
| 34120 | SUPPL | 2004-10-08 |
| 34118 | SUPPL | 2004-10-08 |
| 34117 | SUPPL | 2004-10-08 |
| 19868 | SUPPL | 2004-10-08 |
| 19866 | SUPPL | 2004-10-08 |
| 19865 | SUPPL | 2004-10-08 |
| 12083 | SUPPL | 2004-04-05 |
| 1834 | SUPPL | 2004-03-28 |
| 34119 | SUPPL | 2002-08-07 |
| 19867 | SUPPL | 2002-08-07 |