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 44.

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-2987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-295aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-298869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-293f01610625f2…
2019-12-14 00:12 UTC2019-12N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-083f01610625f2…
2019-09-15 20:21 UTC2019-09N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29b00525d2431f…
2019-09-15 20:21 UTC2019-09N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29ea99ee380514…
2019-07-19 19:46 UTC2019-07N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-296a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-291c564ffb4f44…
2024-02-18 07:12 UTC2024-02N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-299b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-293f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29053a50430f4f…
2023-05-13 08:27 UTC2023-05N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-293bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-293a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-083a93d1ddd44b…

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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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