FDA.reportPublic FDA data

Application 021697

Type
NDA
Sponsor
CUMBERLAND PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VAPRISOLCONIVAPTAN HYDROCHLORIDEINJECTABLE;INTRAVENOUS20MG/4ML (5MG/ML)NoNo
002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINERCONIVAPTAN HYDROCHLORIDEINJECTABLE;INTRAVENOUS20MG/100ML (0.2MG/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021697-001VAPRISOLCONIVAPTAN HYDROCHLORIDE20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29
N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINERCONIVAPTAN HYDROCHLORIDE20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29782e0a99824c…
2021-12-28 21:50 UTC2021-12N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08782e0a99824c…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021697-00157236062019-12-15U-868Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021697-00157236062019-12-15U-698Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021697-00257236062019-12-15U-868Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021697-00257236062019-12-15U-698Drug substance, Drug product74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021697-00157236062019-12-15U-868Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021697-00157236062019-12-15U-698Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021697-00257236062019-12-15U-868Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021697-00257236062019-12-15U-698Drug substance, Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021697-00157236062019-12-15U-868Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021697-00157236062019-12-15U-698Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021697-00257236062019-12-15U-868Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021697-00257236062019-12-15U-698Drug substance, Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021697-00157236062019-12-15U-868Drug substance, Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021697-00157236062019-12-15U-698Drug substance, Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021697-00257236062019-12-15U-868Drug substance, Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021697-00257236062019-12-15U-698Drug substance, Drug productea99ee380514…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-1602Vaprisolconivaptan hydrochlorideAstellas Pharma US, Inc.NDACurrent
66220-160VAPRISOL DEXTROSE IN PLASTIC CONTAINERconivaptan hydrochlorideCumberland Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45620SUPPL2016-10-17
45549SUPPL2016-10-17
16218SUPPL2012-02-06
6007SUPPL2012-02-03
16217SUPPL2010-06-03
6006SUPPL2010-06-02
37474SUPPL2008-11-07
6005SUPPL2008-10-14
42274ORIG2006-03-24
28397ORIG2006-01-06
37473ORIG2005-12-30