FDA.reportPublic FDA data

Application 019951

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETROVIRZIDOVUDINEINJECTABLE;INJECTION10MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N019951-001RETROVIRZIDOVUDINE10MG/MLINJECTABLE / INJECTIONRLD, RS1990-02-02

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019951-001RETROVIR10MG/MLINJECTABLE / INJECTIONRLD, RS1990-02-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019951-001RETROVIR10MG/MLINJECTABLE / INJECTIONRLD, RS1990-02-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019951-001RETROVIR10MG/MLINJECTABLE / INJECTIONRLD, RS1990-02-02cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019951-001RETROVIR10MG/MLINJECTABLE / INJECTIONRLD, RS1990-02-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N019951-001AP174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019951-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N019951-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019951-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019951-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019951-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N019951-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019951-001AP1ea99ee380514…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZidovudineZIDOVUDINECoupler LLC437f55b2-f6d9-0065-e063-6294a90ab9292026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIDOVUDINE
ZidovudineZIDOVUDINEAurobindo Pharma Limited51abd2ce-6be1-412d-b806-5f24935ac5e32025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIDOVUDINE
ZidovudineZIDOVUDINEAurobindo Pharma Limited9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf2025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIDOVUDINE
ZidovudineZIDOVUDINEAurobindo Pharma Limitede7c8ddef-005d-4f1c-8c1a-ea84044ab4d42024-01-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIDOVUDINE
ZidovudineZIDOVUDINECamber Pharmaceuticals, Inc.ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f42023-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIDOVUDINE

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80882SUPPL 2025-01-21
80881SUPPL 2025-01-21
65921SUPPL2021-01-19
63638SUPPL2019-12-20
55437SUPPL2018-09-12
55426SUPPL2018-09-11
50551SUPPL2017-12-01
50528SUPPL2017-11-29
48023SUPPL2017-04-14
48007SUPPL2017-04-13
47440SUPPL2017-03-03
47363SUPPL2017-02-28
12095SUPPL2015-01-08
19882SUPPL2014-12-31
34134SUPPL2012-06-06
19881SUPPL2012-06-05
1847SUPPL2011-11-28
34133SUPPL2011-11-25
1846SUPPL2006-11-22
34132SUPPL2006-07-13
1845SUPPL2006-07-13
1843SUPPL2004-06-16
1844SUPPL2003-08-15
34131SUPPL2003-08-14
12094SUPPL2003-08-06
12093SUPPL2003-06-10
1842SUPPL2002-02-21