Application 021078
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MALARONE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | TABLET;ORAL | 250MG;100MG | Yes | Yes |
| 002 | MALARONE PEDIATRIC | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | TABLET;ORAL | 62.5MG;25MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021078-001 | MALARONE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 |
| N021078-002 | MALARONE PEDIATRIC | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021078-001 | AB |
| N021078-002 | 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 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021078-001 | MALARONE | 250MG;100MG | TABLET / ORAL | AB | RLD, RS | 2000-07-14 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021078-002 | MALARONE PEDIATRIC | 62.5MG;25MG | TABLET / ORAL | AB | RLD | 2000-07-14 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021078-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021078-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021078-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021078-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021078-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021078-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021078-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021078-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021078-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021078-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021078-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021078-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021078-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021078-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021078-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021078-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021078-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021078-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021078-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021078-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021078-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021078-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021078-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021078-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021078-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021078-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021078-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021078-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021078-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021078-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021078-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021078-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021078-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021078-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021078-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021078-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021078-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021078-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021078-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021078-002 | AB | 1 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| MALARONE | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | GlaxoSmithKline LLC | fc22e8d8-3bfb-4f70-a599-dd81262a4887 | 2026-06-10 | Warnings, Adverse reactions | 021078 NDA021078 0173-0675 0173-0676 |
| Atovaquone and Proguanil HCl | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | A-S Medication Solutions | 593baf3d-bd9e-4a44-8f90-125aa4a7a99e | 2023-10-23 | Warnings, Adverse reactions | 021078 NDA021078 50090-2980 |
| Atovaquone and Proguanil HCl | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | Prasco Laboratories | 7069521a-c7f9-4e8d-99b8-0cb5c971e7cf | 2022-05-06 | Warnings, Adverse reactions | 021078 NDA021078 66993-060 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0675 | MALARONE | atovaquone and proguanil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0675 | MALARONE | atovaquone and proguanil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0675 | MALARONE | atovaquone and proguanil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0675 | MALARONE | atovaquone and proguanil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0675 | MALARONE | atovaquone and proguanil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0676 | MALARONE | atovaquone and proguanil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0676 | MALARONE | atovaquone and proguanil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0676 | MALARONE | atovaquone and proguanil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0676 | MALARONE | atovaquone and proguanil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0676 | MALARONE | atovaquone and proguanil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-522 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 50090-0687 | MALARONE | atovaquone and proguanil hydrochloride | A-S Medication Solutions | NDA | Current |
| 50090-0687 | MALARONE | atovaquone and proguanil hydrochloride | A-S Medication Solutions | NDA | Current |
| 50090-0688 | MALARONE | atovaquone and proguanil hydrochloride | A-S Medication Solutions | NDA | Current |
| 50090-2980 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-2980 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-2980 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-2980 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 55289-747 | MALARONE | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-747 | MALARONE | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-747 | MALARONE | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-747 | MALARONE | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-747 | MALARONE | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-747 | MALARONE | atovaquone and proguanil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 63629-5531 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-5531 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-5531 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-5531 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 66993-060 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-060 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-060 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-060 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-060 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-060 | Atovaquone and Proguanil HCl | atovaquone and proguanil hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85522 | SUPPL | 2026-03-24 |
| 85521 | SUPPL | 2026-03-24 |
| 57876 | SUPPL | 2019-03-04 |
| 57818 | SUPPL | 2019-02-27 |
| 14310 | SUPPL | 2013-03-01 |
| 4238 | SUPPL | 2013-03-01 |
| 26668 | SUPPL | 2009-11-09 |
| 36030 | SUPPL | 2009-01-02 |
| 4237 | SUPPL | 2008-12-29 |
| 14309 | SUPPL | 2008-06-12 |
| 26667 | SUPPL | 2008-05-09 |
| 4236 | SUPPL | 2008-01-09 |
| 41935 | SUPPL | 2006-07-10 |
| 41934 | SUPPL | 2006-07-10 |
| 21424 | SUPPL | 2006-07-10 |
| 21423 | SUPPL | 2006-07-10 |
| 36029 | SUPPL | 2005-03-03 |
| 26666 | SUPPL | 2005-03-03 |
| 14308 | SUPPL | 2005-03-03 |
| 4235 | SUPPL | 2005-03-03 |
| 14307 | SUPPL | 2004-12-03 |
| 26665 | SUPPL | 2004-12-02 |
| 26662 | SUPPL | 2004-09-07 |
| 14305 | SUPPL | 2004-09-07 |
| 36028 | SUPPL | 2003-12-08 |
| 26664 | SUPPL | 2003-12-08 |
| 36027 | ORIG | 2003-06-16 |
| 21422 | ORIG | 2003-06-16 |
| 4234 | ORIG | 2003-06-16 |
| 26663 | SUPPL | 2002-08-02 |
| 14306 | SUPPL | 2002-08-02 |
| 26661 | SUPPL | 2002-02-28 |