Application 022292

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001APTIVUSTIPRANAVIRSOLUTION;ORAL100MG/MLYesYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022292-001APTIVUSTIPRANAVIR100MG/MLSOLUTION / ORALRLD2008-06-23

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022292-001APTIVUS100MG/MLSOLUTION / ORALRLD2008-06-23a50c72e98297…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0002AptivustipranavirBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0002AptivustipranavirBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0002AptivustipranavirBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0002AptivustipranavirBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63655SUPPL2020-06-22
63654SUPPL2020-06-22
63653SUPPL2020-06-22
63632SUPPL2020-06-19
54856SUPPL2018-07-06
54717SUPPL2018-06-28
45376SUPPL2016-09-23
45344SUPPL2016-09-20
38528SUPPL2015-04-07
29547SUPPL2015-04-01
38527SUPPL2014-04-08
29546SUPPL2014-04-08
29545SUPPL2012-02-27
17212SUPPL2012-02-22
29544SUPPL2011-04-07
38526SUPPL2011-04-06
7197SUPPL2010-09-07
38525SUPPL2010-08-16
44728ORIG2010-05-12
42481ORIG2010-05-12
17211SUPPL2010-05-07
7196SUPPL2010-05-03
38524SUPPL2009-06-24
7195SUPPL2009-06-24
17210ORIG2008-06-26
7194ORIG2008-06-26