Home Applications 020379 Application 020379
Type NDA
Sponsor PHARMACIA AND UPJOHN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Yes No 002 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Yes Yes 003 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.005MG/VIAL Yes No 004 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.04MG/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020379-001 CAVERJECT ALPROSTADIL 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 N020379-002 CAVERJECT ALPROSTADIL 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 N020379-003 CAVERJECT ALPROSTADIL 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 N020379-004 CAVERJECT ALPROSTADIL 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table 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 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0009-3701 Caverject Alprostadil Pharmacia and Upjohn Company LLC NDA Current 0009-7686 Caverject Alprostadil Pharmacia and Upjohn Company LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 73050 SUPPL 2022-12-27 73038 SUPPL 2022-12-27 50643 SUPPL 2017-12-07 50642 SUPPL 2017-12-07 50635 SUPPL 2017-12-07 50634 SUPPL 2017-12-07 50633 SUPPL 2017-12-07 50632 SUPPL 2017-12-07 12502 SUPPL 2016-05-06 2426 SUPPL 2016-05-06 34574 SUPPL 2014-06-17 24870 SUPPL 2014-06-17 2425 SUPPL 2003-09-09 2424 SUPPL 2002-01-15 20619 SUPPL 1998-03-26