Application 202659
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | TABLET;ORAL | EQ 100MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202659-001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | |
| A202659-002 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | |
| A202659-003 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202659-001 | AB |
| A202659-002 | AB |
| A202659-003 | 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 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202659-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202659-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202659-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-11 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202659-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202659-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202659-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202659-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202659-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202659-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202659-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202659-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202659-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202659-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202659-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202659-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202659-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202659-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202659-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202659-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202659-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202659-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202659-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202659-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202659-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202659-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202659-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202659-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202659-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202659-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202659-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202659-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202659-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202659-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202659-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202659-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202659-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202659-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202659-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202659-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202659-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202659-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202659-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202659-001 | AB | 1 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| Sildenafil | SILDENAFIL | REMEDYREPACK INC. | 99bc66a4-05d1-4372-a25a-1153d7af580e | 2026-07-14 | Warnings, Adverse reactions | 202659 ANDA202659 70518-1844 |
| Sildenafil | SILDENAFIL | PD-Rx Pharmaceuticals, Inc. | e1af7b6a-378e-4337-858f-85a926eec102 | 2026-07-07 | Warnings, Adverse reactions | 202659 ANDA202659 72789-098 |
| Sildenafil | SILDENAFIL | PD-Rx Pharmaceuticals, Inc. | 4e3034af-bee5-4df4-8beb-fbd2b510ad73 | 2026-07-07 | Warnings, Adverse reactions | 202659 ANDA202659 72789-103 |
| Sildenafil | SILDENAFIL | Bryant Ranch Prepack | e22902bd-e5a8-4df6-ae77-8a0a1484cc50 | 2026-06-29 | Warnings, Adverse reactions | 202659 ANDA202659 71335-1028 |
| Sildenafil | SILDENAFIL | Camber Pharmaceuticals, Inc. | dc1c1ddb-f16b-4d7a-aabe-cf8bdf8b7998 | 2026-05-22 | Warnings, Adverse reactions | 202659 ANDA202659 31722-711 31722-710 31722-709 |
| Sildenafil | SILDENAFIL | Camber Pharmaceuticals, Inc. | 96ab1605-e171-4e86-b357-2d9378f7a05a | 2026-05-18 | Warnings, Adverse reactions | 202659 ANDA202659 31722-965 31722-967 31722-966 |
| Sildenafil | SILDENAFIL | Northwind Health Company, LLC | f3089ee6-190d-4749-e053-2a95a90a15d8 | 2026-01-01 | Warnings, Adverse reactions | 202659 ANDA202659 |
| Sildenafil | SILDENAFIL | Preferred Pharmaceuticals, Inc. | 174ef537-e3e6-42bd-a478-47b930ddc761 | 2025-09-22 | Warnings, Adverse reactions | 202659 ANDA202659 68788-7879 |
| SILDENAFIL | SILDENAFIL | DIRECT RX | a84a418a-155c-7be7-e053-2995a90a8158 | 2025-01-17 | Warnings, Adverse reactions | 202659 ANDA202659 72189-069 |
| Sildenafil | SILDENAFIL | Bryant Ranch Prepack | f66ce83b-bad6-4180-a8c4-8475a8ec50b7 | 2024-08-21 | Warnings, Adverse reactions | 202659 ANDA202659 71335-1088 |
| Sildenafil | SILDENAFIL | NuCare Pharmaceuticals,Inc. | 78101030-ef1d-44b9-e053-2991aa0a158d | 2024-06-12 | Warnings, Adverse reactions | 202659 ANDA202659 68071-4599 |
| Sildenafil | SILDENAFIL | NuCare Pharmaceuticals,Inc. | 7925711e-2e89-fd93-e053-2991aa0a507f | 2024-06-12 | Warnings, Adverse reactions | 202659 ANDA202659 68071-4617 |
| Sildenafil | SILDENAFIL | NuCare Pharmaceuticals,Inc. | 7d68a3d3-590b-0bd9-e053-2a91aa0ae8cd | 2024-06-12 | Warnings, Adverse reactions | 202659 ANDA202659 68071-4674 |
| Sildenafil | SILDENAFIL | A-S Medication Solutions | eaeab74e-38cc-4621-9ce8-8a5d74a29a9e | 2023-11-07 | Warnings, Adverse reactions | 202659 ANDA202659 50090-5325 |
| Sildenafil | SILDENAFIL | A-S Medication Solutions | 997197bf-7706-4e12-97df-b0a9ea6d3a10 | 2023-07-28 | Warnings, Adverse reactions | 202659 ANDA202659 50090-5415 |
| Sildenafil | SILDENAFIL | A-S Medication Solutions | 3145ceda-8c1e-4601-8a9d-5fc4978226d6 | 2023-05-23 | Warnings, Adverse reactions | 202659 ANDA202659 50090-5235 |
| Sildenafil | SILDENAFIL | XLCARE Pharmaceuticals INC. | ae732301-384f-43ae-80d1-5e3784fe1dca | 2023-01-17 | Warnings, Adverse reactions | 202659 ANDA202659 72865-102 72865-103 72865-101 |
| Sildenafil | SILDENAFIL | Proficient Rx LP | 0aced3eb-cb0b-4135-905c-b274505aa740 | 2022-05-02 | Warnings, Adverse reactions | 202659 ANDA202659 71205-498 |
| Sildenafil | SILDENAFIL | Proficient Rx LP | 5a14da46-a3ac-495f-bd9c-6e46d1ba6d7c | 2022-04-01 | Warnings, Adverse reactions | 202659 ANDA202659 71205-542 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-709 | Sildenafil | Sildenafil | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-710 | Sildenafil | Sildenafil | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-711 | Sildenafil | Sildenafil | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-965 | Sildenafil | Sildenafil | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-966 | Sildenafil | Sildenafil | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-967 | Sildenafil | Sildenafil | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50090-5235 | Sildenafil | Sildenafil | A-S Medication Solutions | ANDA | Current |
| 50090-5325 | Sildenafil | Sildenafil | A-S Medication Solutions | ANDA | Current |
| 50090-5325 | Sildenafil | Sildenafil | A-S Medication Solutions | ANDA | Current |
| 50090-5415 | Sildenafil | Sildenafil | A-S Medication Solutions | ANDA | Current |
| 50436-0710 | Sildenafil | Sildenafil | Unit Dose Services | ANDA | Current |
| 50436-0710 | Sildenafil | Sildenafil | Unit Dose Services | ANDA | Current |
| 50436-0711 | Sildenafil | Sildenafil | Unit Dose Services | ANDA | Current |
| 61919-755 | SILDENAFIL | SILDENAFIL | DIRECT RX | ANDA | Current |
| 61919-755 | SILDENAFIL | SILDENAFIL | DIRECT RX | ANDA | Current |
| 61919-755 | SILDENAFIL | SILDENAFIL | DIRECT RX | ANDA | Current |
| 61919-755 | SILDENAFIL | SILDENAFIL | DIRECT RX | ANDA | Current |
| 68071-2552 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2689 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4599 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-4599 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4599 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4599 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4599 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4617 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4617 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4674 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4674 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4674 | Sildenafil | Sildenafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7879 | Sildenafil | Sildenafil | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7879 | Sildenafil | Sildenafil | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1844 | Sildenafil | Sildenafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-1844 | Sildenafil | Sildenafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-1844 | Sildenafil | Sildenafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-1844 | Sildenafil | Sildenafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-2128 | Sildenafil | Sildenafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-2128 | Sildenafil | Sildenafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-2128 | Sildenafil | Sildenafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-2128 | Sildenafil | Sildenafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-2128 | Sildenafil | Sildenafil | REMEDYREPACK INC. | ANDA | Current |
| 70934-472 | Sildenafil | Sildenafil | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-472 | Sildenafil | Sildenafil | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-498 | Sildenafil | Sildenafil | Proficient Rx LP | ANDA | Current |
| 71205-498 | Sildenafil | Sildenafil | Proficient Rx LP | ANDA | Current |
| 71205-498 | Sildenafil | Sildenafil | Proficient Rx LP | ANDA | Current |
| 71205-542 | Sildenafil | Sildenafil | Proficient Rx LP | ANDA | Current |
| 71205-542 | Sildenafil | Sildenafil | Proficient Rx LP | ANDA | Current |
| 71335-1028 | Sildenafil | Sildenafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1028 | Sildenafil | Sildenafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1028 | Sildenafil | Sildenafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1028 | Sildenafil | Sildenafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1088 | Sildenafil | Sildenafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1088 | Sildenafil | Sildenafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1088 | Sildenafil | Sildenafil | Bryant Ranch Prepack | ANDA | Current |
| 72189-069 | SILDENAFIL | SILDENAFIL | DIRECT RX | ANDA | Current |
| 72189-069 | SILDENAFIL | SILDENAFIL | DIRECT RX | ANDA | Current |
| 72789-098 | Sildenafil | Sildenafil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-098 | Sildenafil | Sildenafil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-098 | Sildenafil | Sildenafil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-098 | Sildenafil | Sildenafil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-103 | Sildenafil | Sildenafil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-103 | Sildenafil | Sildenafil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-103 | Sildenafil | Sildenafil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72865-101 | Sildenafil | Sildenafil | XLCARE Pharmaceuticals INC. | ANDA | Current |
| 72865-102 | Sildenafil | Sildenafil | XLCARE Pharmaceuticals INC. | ANDA | Current |
| 72865-103 | Sildenafil | Sildenafil | XLCARE Pharmaceuticals INC. | ANDA | Current |
| 76519-1216 | SILDENAFIL | SILDENAFIL | H.J. Harkins Company, Inc. | ANDA | Current |
| 76519-1218 | SILDENAFIL | SILDENAFIL | H.J. Harkins Company, Inc. | ANDA | Current |