Home Applications 065176 Application 065176
Type ANDA
Sponsor HANFORD GC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL No No 002 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A065176-001 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 A065176-002 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 of 3 · 88 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 2019-12-13 00:20 UTC 2019-12 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065176-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065176-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2005-11-30 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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 · 1 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 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 44567-210 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-210 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-210 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-210 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-210 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-210 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-210 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-210 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-211 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-211 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-211 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-211 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-211 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-211 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-211 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current 44567-211 Ampicillin and Sulbactam Ampicillin and Sulbactam WG Critical Care, LLC ANDA Current