Application 202506
- Type
- ANDA
- Sponsor
- WATSON LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | TABLET; ORAL | 25MG | No | No |
| 002 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | TABLET; ORAL | 50MG | No | No |
| 003 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | TABLET; ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202506-001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | ||
| A202506-002 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | ||
| A202506-003 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202506-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | 2020-11-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202506-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | 2020-11-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202506-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | 2020-11-25 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202506-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202506-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202506-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A202506-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A202506-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A202506-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A202506-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A202506-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A202506-003 | AB | 1 | 8869cabd3fbd… |
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 |
|---|---|---|---|---|---|---|
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | PD-Rx Pharmaceuticals, Inc. | 00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b | 2026-07-29 | Warnings, Adverse reactions | SILDENAFIL CITRATE SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | PD-Rx Pharmaceuticals, Inc. | f1122baa-8dee-43fc-bd3d-501a55b696b3 | 2026-07-29 | Warnings, Adverse reactions | SILDENAFIL CITRATE SILDENAFIL CITRATE |
| Sildenafil | SILDENAFIL CITRATE | Yaral Pharma Inc. | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2026-07-17 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Vybrique | SILDENAFIL CITRATE | IBSA Pharma Inc. | 9213fec1-e0c0-4ef7-9718-d97922a3f4d8 | 2026-07-08 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Sildenafil | SILDENAFIL CITRATE | Eugia US LLC | bb92d686-a81e-4b91-8048-693af0534cb3 | 2026-07-01 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Sildenafil Citrate | SILDENAFIL | Northwind Health Company, LLC | 471b8574-cb2a-1670-e063-6394a90a2a84 | 2026-06-23 | Warnings, Adverse reactions | Sildenafil Citrate |
| Sildenafil Citrate | SILDENAFIL | Bryant Ranch Prepack | 824dcd79-bc82-4b3a-8028-3c1bca1a7a0a | 2026-06-18 | Warnings, Adverse reactions | Sildenafil Citrate |
| Sildenafil Citrate | SILDENAFIL | Proficient Rx LP | 3522bdcc-8113-4562-8ca1-f3eb884beaea | 2026-06-01 | Warnings, Adverse reactions | Sildenafil Citrate |
| SILDENAFIL CITRATE | SILDENAFIL | PD-Rx Pharmaceuticals, Inc. | ace2bb56-4992-49fe-9311-535b12eea9b4 | 2026-05-27 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL | PD-Rx Pharmaceuticals, Inc. | 78c4551c-b922-43c9-9a5a-66377ea07bc2 | 2026-05-27 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL | Redpharm Drug | 52614168-3a9e-335d-e063-6394a90ac27f | 2026-05-22 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL | NuCare Pharmaceuticals, Inc. | 36da8e3a-d17c-e42f-e063-6394a90a1ece | 2026-05-18 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | Umedica Laboratories USA Inc. | 90477a51-63ba-43f4-a74b-4659a946093c | 2026-05-13 | Warnings, Adverse reactions | SILDENAFIL CITRATE SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | NIVAGEN PHARMACEUTICALS, INC. | 5ac95dd0-57e4-495c-bf8d-b2e5bbe33e20 | 2026-04-27 | Warnings, Adverse reactions | SILDENAFIL CITRATE SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL | Preferred Pharmaceuticals Inc. | 5f9ff0bb-5634-437a-96eb-249b910c7e81 | 2026-04-22 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL | Bryant Ranch Prepack | a05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d6 | 2026-03-30 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Sildenafil Citrate | SILDENAFIL | NuCare Pharmaceuticals,Inc. | fbe75c2c-0aff-9ade-e053-6394a90a1ea4 | 2026-03-20 | Warnings, Adverse reactions | Sildenafil Citrate |
| SILDENAFIL CITRATE | SILDENAFIL | Bryant Ranch Prepack | edb0919d-cbf1-4968-b0eb-342aa811c2ce | 2026-03-09 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | Northstar Rx LLC | 8127ff38-2761-49ec-8ce7-7f971f521cfb | 2026-02-26 | Warnings, Adverse reactions | SILDENAFIL CITRATE SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL | Torrent Pharmaceuticals Limited | b48630b1-5208-4d00-b56f-21701f223758 | 2026-02-10 | Warnings, Adverse reactions | SILDENAFIL CITRATE |