Home Applications 090583 Application 090583
Type ANDA
Sponsor SAGENT PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 125MG BASE/VIAL No No 002 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL No No 003 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No 004 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 005 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090583-001 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 A090583-002 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 A090583-003 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 A090583-004 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 A090583-005 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 6 · 215 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 2026-09-14 22:38:34 2026-08 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 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 2 of 2 · 23 matching rows.
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 · 26 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66794-220 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-220 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-220 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-220 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-220 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-221 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-221 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-221 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-221 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-221 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-222 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-222 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-222 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-222 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-222 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-223 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-223 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-223 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-223 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 66794-223 Ampicillin Ampicillin Piramal Critical Care Inc ANDA Current 70594-084 Ampicillin AMPICILLIN SODIUM Xellia Pharmaceuticals USA LLC ANDA Current 70594-085 Ampicillin AMPICILLIN SODIUM Xellia Pharmaceuticals USA LLC ANDA Current 70594-086 Ampicillin AMPICILLIN SODIUM Xellia Pharmaceuticals USA LLC ANDA Current 70594-087 Ampicillin AMPICILLIN SODIUM Xellia Pharmaceuticals USA LLC ANDA Current 71872-7280 Ampicillin AMPICILLIN SODIUM Medical Purchasing Solutions, LLC ANDA Current 71872-7286 Ampicillin AMPICILLIN SODIUM Medical Purchasing Solutions, LLC ANDA Current