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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29e64feba35796…
2022-09-29 23:25 UTC2022-09N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021697-001VAPRISOL20MG/4ML (5MG/ML)INJECTABLE / INTRAVENOUS2005-12-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021697-002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER20MG/100ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2008-10-08a50c72e98297…

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