FDA.reportPublic FDA data

Application 208990

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABACAVIR SULFATE AND LAMIVUDINEABACAVIR SULFATE; LAMIVUDINETABLET;ORALEQ 600MG BASE;300MGNoNo

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
A208990-001ABACAVIR SULFATE AND LAMIVUDINEABACAVIR SULFATE; LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15

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 UTC2022-10A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15a50c72e98297…

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1049Abacavir and lamivudineAbacavir and lamivudineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1049Abacavir and lamivudineAbacavir and lamivudineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1049Abacavir and lamivudineAbacavir and lamivudineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1049Abacavir and lamivudineAbacavir and lamivudineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1053Abacavir and lamivudineAbacavir and lamivudineZydus Lifesciences LimitedANDACurrent
70771-1053Abacavir and lamivudineAbacavir and lamivudineCadila Healthcare LimitedANDACurrent
70771-1053Abacavir and lamivudineAbacavir and lamivudineCadila Healthcare LimitedANDACurrent
70771-1053Abacavir and lamivudineAbacavir and lamivudineCadila Healthcare LimitedANDACurrent
70771-1053Abacavir and lamivudineAbacavir and lamivudineCadila Healthcare LimitedANDACurrent