Application 021212
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CAVERJECT IMPULSE | ALPROSTADIL | INJECTABLE;INJECTION | 0.01MG/VIAL | No | No |
| 002 | CAVERJECT IMPULSE | ALPROSTADIL | INJECTABLE;INJECTION | 0.02MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021212-001 | CAVERJECT IMPULSE | ALPROSTADIL | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | ||
| N021212-002 | CAVERJECT IMPULSE | ALPROSTADIL | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 |
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 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021212-001 | CAVERJECT IMPULSE | 0.01MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021212-002 | CAVERJECT IMPULSE | 0.02MG/VIAL | INJECTABLE / INJECTION | 2002-06-11 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Caverject Impulse | ALPROSTADIL | Pharmacia & Upjohn Company LLC | 4dec1dbd-c63b-4a1b-81cb-c8d29696cc40 | 2024-02-29 | Warnings, Adverse reactions | 021212 NDA021212 0009-5182 0009-5181 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0009-5181 | Caverject Impulse | Alprostadil | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-5181 | Caverject Impulse | Alprostadil | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-5182 | Caverject Impulse | Alprostadil | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-5182 | Caverject Impulse | Alprostadil | Pharmacia and Upjohn Company LLC | NDA | Current |
| 63539-121 | Caverject Impulse | Alprostadil | U.S. Pharmaceuticals | NDA | Current |
| 63539-221 | Caverject Impulse | Alprostadil | U.S. Pharmaceuticals | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73051 | SUPPL | 2022-12-27 |
| 73039 | SUPPL | 2022-12-27 |
| 45756 | SUPPL | 2016-11-01 |
| 45755 | SUPPL | 2016-11-01 |
| 45702 | SUPPL | 2016-10-28 |
| 45701 | SUPPL | 2016-10-28 |
| 14642 | SUPPL | 2016-05-06 |
| 4649 | SUPPL | 2016-05-06 |
| 36365 | SUPPL | 2015-11-04 |
| 27082 | SUPPL | 2015-10-28 |
| 27081 | SUPPL | 2014-06-12 |
| 14641 | SUPPL | 2013-12-23 |
| 27080 | SUPPL | 2013-12-20 |
| 4648 | SUPPL | 2003-09-09 |
| 36364 | ORIG | 2002-06-11 |
| 21511 | ORIG | 2002-06-11 |
| 4647 | ORIG | 2002-06-11 |