Application 020755
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.005MG/ML | No | No |
| 002 | CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.01MG/ML | No | No |
| 003 | CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.02MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020755-001 | CAVERJECT | ALPROSTADIL | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | ||
| N020755-002 | CAVERJECT | ALPROSTADIL | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | ||
| N020755-003 | CAVERJECT | ALPROSTADIL | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020755-002 | CAVERJECT | 0.01MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020755-003 | CAVERJECT | 0.02MG/ML | INJECTABLE / INJECTION | 1997-10-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020755-001 | CAVERJECT | 0.005MG/ML | INJECTABLE / INJECTION | 1997-10-31 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| PROSTIN VR PEDIATRIC | ALPROSTADIL | Pharmacia & Upjohn Company LLC | 930f8c02-46a8-4cff-a484-660468ab23c3 | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | ALPROSTADIL |
| PROSTIN VR PEDIATRIC | ALPROSTADIL | Pharmacia & Upjohn Company LLC | dea460fa-d05e-4191-8461-f185a711ad89 | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | ALPROSTADIL |
| Alprostadil | ALPROSTADIL | Meitheal Pharmaceuticals Inc. | 35d229e1-6947-435c-bf54-bfa09cca7e53 | 2024-06-04 | Boxed warning, Warnings, Adverse reactions | ALPROSTADIL |
| Caverject | ALPROSTADIL | Pharmacia & Upjohn Company LLC | a295fc1e-d82c-4f44-bc2d-a552bf594c98 | 2024-05-13 | Warnings, Adverse reactions | Caverject ALPROSTADIL |
| Edex | ALPROSTADIL | Endo USA, Inc. | e8b8ec8d-1318-43e4-a182-446e9f9579de | 2024-03-27 | Warnings, Adverse reactions | ALPROSTADIL |
| Caverject Impulse | ALPROSTADIL | Pharmacia & Upjohn Company LLC | 4dec1dbd-c63b-4a1b-81cb-c8d29696cc40 | 2024-02-29 | Warnings, Adverse reactions | ALPROSTADIL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.