Home Applications 091246 Application 091246
Type ANDA
Sponsor SAGENT PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXACILLIN SODIUM OXACILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No Yes 002 OXACILLIN SODIUM OXACILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091246-001 OXACILLIN SODIUM OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 A091246-002 OXACILLIN SODIUM OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30
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 3 · 82 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 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2012-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091246-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091246-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-03-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
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 · 3 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 25021-146 Oxacillin oxacillin sodium Sagent Pharmaceuticals ANDA Current 25021-162 Oxacillin oxacillin sodium Sagent Pharmaceuticals ANDA Current 25021-162 Oxacillin oxacillin sodium Sagent Pharmaceuticals ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22724 ORIG 2012-09-12