Home Applications 214313 Application 214313
Type NDA
Sponsor BAXTER HLTHCARE CORP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NOREPINEPHRINE BITARTRATE;DEXTROSE NOREPINEPHRINE BITARTRATE;DEXTROSE INJECTABLE;INJECTION 16 MCG/ML No No 002 NOREPINEPHRINE BITARTRATE;DEXTROSE NOREPINEPHRINE BITARTRATE;DEXTROSE INJECTABLE;INJECTION 32 MCG/ML Yes No 003 NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE NOREPINEPHRINE BITARTRATE SOLUTION;INTRAVENOUS EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) Yes Yes 004 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE NOREPINEPHRINE BITARTRATE SOLUTION;INTRAVENOUS EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) Yes Yes 005 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE NOREPINEPHRINE BITARTRATE SOLUTION;INTRAVENOUS EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) Yes Yes 006 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE NOREPINEPHRINE BITARTRATE SOLUTION;INTRAVENOUS EQ 16MG BASE/250ML (EQ 64MCG 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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214313-001 NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE NOREPINEPHRINE BITARTRATE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-01-15 N214313-002 NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE NOREPINEPHRINE BITARTRATE EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-01-15 N214313-003 NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE NOREPINEPHRINE BITARTRATE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2023-11-21 N214313-004 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE NOREPINEPHRINE BITARTRATE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-06 N214313-005 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE NOREPINEPHRINE BITARTRATE EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-06 N214313-006 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE NOREPINEPHRINE BITARTRATE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214313-001 12097170 2041-03-08 U-3995 Drug product 2024-09-30 N214313-001 12290494 2041-03-08 Drug product 2025-05-16 N214313-002 12097170 2041-03-08 U-3995 Drug product 2024-09-30 N214313-002 12290494 2041-03-08 Drug product 2025-05-16 N214313-003 12097170 2041-03-08 U-3995 Drug product 2024-09-30
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.
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 2026-08-01 22:54:32 2026-06 N214313-001 NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-01-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N214313-002 NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-01-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N214313-003 NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2023-11-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N214313-004 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N214313-005 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N214313-006 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 2026-08-01 22:54:32 2026-06 N214313-001 12097170 2041-03-08 U-3995 Drug product 2024-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N214313-001 12290494 2041-03-08 Drug product 2025-05-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N214313-002 12097170 2041-03-08 U-3995 Drug product 2024-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N214313-002 12290494 2041-03-08 Drug product 2025-05-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N214313-003 12097170 2041-03-08 U-3995 Drug product 2024-09-30 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0338-0108 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0108 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0108 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0108 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0108 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0108 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0112 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0112 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0112 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0112 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0112 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current 0338-0112 NOREPINEPHRINE BITARTRATE norepinephrine bitartrate Baxter Healthcare Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84997 SUPPL 2026-02-11 84970 SUPPL 2026-02-09 80176 SUPPL 2024-11-07 80014 SUPPL 2024-10-28 78981 SUPPL 2024-07-05 71848 SUPPL 2022-08-19 71840 SUPPL 2022-08-18 68094 ORIG 2021-07-15 65935 ORIG 2021-01-19 65914 ORIG 2021-01-15