Home Applications 020978 Application 020978
Type NDA
Sponsor VIIV HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZIAGEN ABACAVIR SULFATE SOLUTION;ORAL EQ 20MG BASE/ML Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020978-001 ZIAGEN ABACAVIR SULFATE EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020978-001 AA
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 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020978-001 6641843 2019-02-04 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020978-001 6641843*PED 2019-08-04 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N020978-001 6641843 2019-02-04 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020978-001 6641843*PED 2019-08-04 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020978-001 6641843 2019-02-04 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020978-001 6641843*PED 2019-08-04 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020978-001 6641843 2019-02-04 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020978-001 6641843*PED 2019-08-04 Pediatric extension ea99ee380514…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZIAGEN ABACAVIR SULFATE ViiV Healthcare Company ca73b519-015a-436d-aa3c-af53492825a1 2023-09-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020978 application number: NDA020978 ndc (product): 49702-222
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49702-222 ZIAGEN abacavir sulfate ViiV Healthcare Company NDA Current 49702-222 ZIAGEN abacavir sulfate ViiV Healthcare Company NDA Current 49702-222 ZIAGEN abacavir sulfate ViiV Healthcare Company NDA Current 49702-222 ZIAGEN abacavir sulfate ViiV Healthcare Company NDA Current 49702-222 ZIAGEN abacavir sulfate ViiV Healthcare Company NDA Current 49702-222 ZIAGEN abacavir sulfate ViiV Healthcare Company NDA Current