Home Applications 050588 Application 050588
Type NDA
Sponsor TELIGENT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFOTAN CEFOTETAN DISODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL Yes No 002 CEFOTAN CEFOTETAN DISODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL Yes No 003 CEFOTAN CEFOTETAN DISODIUM INJECTABLE;INJECTION EQ 10GM 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050588-001 CEFOTAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 N050588-002 CEFOTAN CEFOTETAN DISODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 N050588-003 CEFOTAN CEFOTETAN DISODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1988-04-25
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 4 · 132 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 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050588-001 CEFOTAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD 1985-12-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050588-002 CEFOTAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD 1985-12-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050588-001 CEFOTAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD 1985-12-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050588-002 CEFOTAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD 1985-12-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050588-003 CEFOTAN EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1988-04-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050588-001 CEFOTAN EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050588-002 CEFOTAN EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1985-12-27 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cefotan CEFOTETAN PAI Holdings, LLC dba PAI Pharma f1510f5e-d001-44e0-accb-27cf79fd4f9a 2024-04-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 050588 application number: NDA050588
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52565-052 Cefotan Cefotetan Disodium Teligent Pharma, Inc. NDA Current 52565-053 CEFOTAN cefotetan disodium Teligent Pharma, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57692 ORIG 2019-02-15 47552 SUPPL 2017-03-14 47520 SUPPL 2017-03-10 39014 SUPPL 2004-07-01 30128 SUPPL 2004-07-01 17906 SUPPL 2004-05-28 17907 SUPPL 2003-07-08 7856 SUPPL 2003-07-06 30127 SUPPL 2003-03-10