Application 020895
- Type
- NDA
- Sponsor
- PFIZER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIAGRA | SILDENAFIL CITRATE | TABLET;ORAL | EQ 25MG BASE | Yes | No |
| 002 | VIAGRA | SILDENAFIL CITRATE | TABLET;ORAL | EQ 50MG BASE | Yes | No |
| 003 | VIAGRA | SILDENAFIL CITRATE | TABLET;ORAL | EQ 100MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020895-001 | VIAGRA | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 |
| N020895-002 | VIAGRA | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 |
| N020895-003 | VIAGRA | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020895-001 | AB |
| N020895-002 | AB |
| N020895-003 | 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 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020895-002 | VIAGRA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020895-003 | VIAGRA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 1998-03-27 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020895-001 | VIAGRA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 1998-03-27 | 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 | N020895-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020895-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020895-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020895-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020895-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020895-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020895-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020895-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020895-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020895-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020895-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020895-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020895-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020895-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020895-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020895-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020895-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020895-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020895-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020895-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020895-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020895-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020895-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020895-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020895-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020895-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020895-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020895-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020895-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020895-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020895-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020895-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020895-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020895-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020895-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020895-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020895-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020895-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020895-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020895-001 | AB | 1 | 1e350fbaab3a… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020895-001 | 6469012 | 2019-10-22 | U-155 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020895-001 | 6469012*PED | 2020-04-22 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020895-002 | 6469012 | 2019-10-22 | U-155 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020895-002 | 6469012*PED | 2020-04-22 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020895-003 | 6469012 | 2019-10-22 | U-155 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020895-003 | 6469012*PED | 2020-04-22 | Pediatric extension | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020895-001 | 6469012*PED | 2020-04-22 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020895-002 | 6469012*PED | 2020-04-22 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020895-003 | 6469012*PED | 2020-04-22 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020895-001 | 6469012*PED | 2020-04-22 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020895-002 | 6469012*PED | 2020-04-22 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020895-003 | 6469012*PED | 2020-04-22 | Pediatric extension | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020895-001 | 6469012 | 2019-10-22 | U-155 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020895-001 | 6469012*PED | 2020-04-22 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020895-002 | 6469012 | 2019-10-22 | U-155 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020895-002 | 6469012*PED | 2020-04-22 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020895-003 | 6469012 | 2019-10-22 | U-155 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020895-003 | 6469012*PED | 2020-04-22 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020895-001 | 6469012 | 2019-10-22 | U-155 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020895-001 | 6469012*PED | 2020-04-22 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020895-002 | 6469012 | 2019-10-22 | U-155 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020895-002 | 6469012*PED | 2020-04-22 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020895-003 | 6469012 | 2019-10-22 | U-155 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020895-003 | 6469012*PED | 2020-04-22 | Pediatric extension | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020895-001 | 6469012 | 2019-10-22 | U-155 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020895-001 | 6469012*PED | 2020-04-22 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020895-002 | 6469012 | 2019-10-22 | U-155 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020895-002 | 6469012*PED | 2020-04-22 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020895-003 | 6469012 | 2019-10-22 | U-155 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020895-003 | 6469012*PED | 2020-04-22 | Pediatric extension | ea99ee380514… |
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 Citrate | SILDENAFIL CITRATE | Mylan Pharmaceuticals Inc. | 98a9897b-0cbc-4ea6-9ac2-4dd719a2ede0 | 2024-08-29 | Warnings, Adverse reactions | 020895 NDA020895 59762-0035 59762-0034 59762-0036 |
| Viagra | SILDENAFIL CITRATE | Viatris Specialty LLC | d905dc8d-917f-4ea3-a4ee-a1ecf6967d4e | 2023-11-17 | Warnings, Adverse reactions | 020895 NDA020895 |
| Viagra | SILDENAFIL CITRATE | PFIZER LABORATORIES DIV PFIZER INC | 0b0be196-0c62-461c-94f4-9a35339b4501 | 2017-12-15 | Warnings, Adverse reactions | 020895 NDA020895 0069-4200 0069-4220 0069-4210 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-4200 | Viagra | sildenafil citrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4200 | Viagra | sildenafil citrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4200 | Viagra | sildenafil citrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4210 | Viagra | sildenafil citrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4210 | Viagra | sildenafil citrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4210 | Viagra | sildenafil citrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4220 | Viagra | sildenafil citrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4220 | Viagra | sildenafil citrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4220 | Viagra | sildenafil citrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 21695-157 | Viagra | sildenafil citrate | Rebel Distributors Corp | NDA | Current |
| 21695-158 | Viagra | sildenafil citrate | Rebel Distributors Corp | NDA | Current |
| 43063-256 | Viagra | sildenafil citrate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-256 | Viagra | sildenafil citrate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-256 | Viagra | sildenafil citrate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-256 | Viagra | sildenafil citrate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-256 | Viagra | sildenafil citrate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43353-764 | Viagra | sildenafil citrate | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 43353-764 | Viagra | sildenafil citrate | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 50090-0619 | Viagra | sildenafil citrate | A-S Medication Solutions | NDA | Current |
| 50090-0619 | Viagra | sildenafil citrate | A-S Medication Solutions | NDA | Current |
| 50436-0035 | Sildenafil Citrate | sildenafil citrate | Unit Dose Services | NDA | Current |
| 50436-0035 | Sildenafil Citrate | sildenafil citrate | Unit Dose Services | NDA | Current |
| 50436-0036 | Sildenafil Citrate | sildenafil citrate | Unit Dose Services | NDA | Current |
| 50436-3500 | Sildenafil Citrate | sildenafil citrate | Unit Dose Services | NDA | Current |
| 55154-2736 | Viagra | sildenafil citrate | Cardinal Health | NDA | Current |
| 55289-524 | Viagra | sildenafil citrate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-577 | Viagra | sildenafil citrate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 59762-0034 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0034 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA | Current |
| 59762-0034 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA | Current |
| 59762-0034 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA | Current |
| 59762-0035 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0035 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA | Current |
| 59762-0035 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA | Current |
| 59762-0035 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA | Current |
| 59762-0036 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0036 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA | Current |
| 59762-0036 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA | Current |
| 59762-0036 | Sildenafil Citrate | sildenafil citrate | Greenstone LLC | NDA | Current |
| 63539-421 | Viagra | sildenafil citrate | U.S. Pharmaceuticals | NDA | Current |
| 63539-421 | Viagra | sildenafil citrate | U.S. Pharmaceuticals | NDA | Current |
| 63539-421 | Viagra | sildenafil citrate | U.S. Pharmaceuticals | NDA | Current |
| 63539-422 | Viagra | sildenafil citrate | U.S. Pharmaceuticals | NDA | Current |
| 63539-422 | Viagra | sildenafil citrate | U.S. Pharmaceuticals | NDA | Current |
| 63539-422 | Viagra | sildenafil citrate | U.S. Pharmaceuticals | NDA | Current |
| 63629-6316 | Viagra | sildenafil citrate | Bryant Ranch Prepack | NDA | Current |
| 63629-6316 | Viagra | sildenafil citrate | Bryant Ranch Prepack | NDA | Current |
| 63629-6369 | Viagra | sildenafil citrate | Bryant Ranch Prepack | NDA | Current |
| 63629-6369 | Viagra | sildenafil citrate | Bryant Ranch Prepack | NDA | Current |
| 63629-7273 | Viagra | sildenafil citrate | Bryant Ranch Prepack | NDA | Current |
| 63629-7273 | Viagra | sildenafil citrate | Bryant Ranch Prepack | NDA | Current |
| 63629-7273 | Viagra | sildenafil citrate | Bryant Ranch Prepack | NDA | Current |
| 63629-7273 | Viagra | sildenafil citrate | Bryant Ranch Prepack | NDA | Current |
| 67544-355 | Viagra | sildenafil citrate | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 67544-355 | Viagra | sildenafil citrate | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 67544-356 | Viagra | sildenafil citrate | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 67544-356 | Viagra | sildenafil citrate | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 70518-0953 | Viagra | sildenafil citrate | REMEDYREPACK INC. | NDA | Current |
| 70518-0953 | Viagra | sildenafil citrate | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 50711 | SUPPL | 2017-12-15 |
| 50687 | SUPPL | 2017-12-14 |
| 49505 | SUPPL | 2017-08-22 |
| 49445 | SUPPL | 2017-08-17 |
| 13683 | SUPPL | 2015-09-23 |
| 3670 | SUPPL | 2015-09-17 |
| 35582 | SUPPL | 2015-03-27 |
| 26131 | SUPPL | 2015-03-27 |
| 35581 | SUPPL | 2014-03-11 |
| 35580 | SUPPL | 2014-03-11 |
| 26130 | SUPPL | 2014-03-11 |
| 3669 | SUPPL | 2014-03-11 |
| 3668 | SUPPL | 2011-02-04 |
| 35579 | SUPPL | 2011-01-31 |
| 13682 | SUPPL | 2010-01-20 |
| 3667 | SUPPL | 2010-01-15 |
| 21046 | ORIG | 2009-04-13 |
| 3666 | SUPPL | 2008-08-13 |
| 3665 | SUPPL | 2008-08-13 |
| 3663 | SUPPL | 2008-02-27 |
| 13681 | SUPPL | 2008-02-26 |
| 41785 | SUPPL | 2008-02-19 |
| 41784 | SUPPL | 2008-02-19 |
| 21047 | SUPPL | 2008-02-19 |
| 23608 | ORIG | 2007-10-30 |
| 3664 | SUPPL | 2007-10-22 |
| 35578 | SUPPL | 2007-10-18 |
| 26129 | SUPPL | 2006-10-13 |
| 13680 | SUPPL | 2006-10-11 |
| 3662 | SUPPL | 2006-07-03 |
| 13678 | SUPPL | 2006-06-28 |
| 26128 | SUPPL | 2005-07-15 |
| 13679 | SUPPL | 2005-07-08 |
| 35577 | SUPPL | 2002-09-19 |
| 26127 | SUPPL | 2002-09-19 |
| 26126 | SUPPL | 2002-09-19 |
| 13677 | SUPPL | 2002-09-19 |
| 13676 | SUPPL | 2002-09-19 |
| 3661 | SUPPL | 2002-09-19 |
| 13675 | ORIG | 1998-03-27 |
| 3660 | ORIG | 1998-03-27 |
| 64081 | ORIG | 1900-01-01 |
| 64080 | ORIG | 1900-01-01 |
| 64079 | ORIG | 1900-01-01 |
| 64078 | ORIG | 1900-01-01 |
| 64077 | ORIG | 1900-01-01 |
| 64076 | ORIG | 1900-01-01 |
| 64074 | ORIG | 1900-01-01 |