Home Applications 220315 Application 220315
Type ANDA
Sponsor DR REDDYS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) No No 002 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A220315-001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP 2026-02-25 A220315-002 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP 2026-02-25
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.
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 A220315-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP 2026-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220315-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP 2026-02-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220315-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP 2026-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220315-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP 2026-02-25 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220315-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP 2026-02-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220315-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP 2026-02-25 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 26 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride DEXMEDETOMIDINE HYDROCHLORIDE Sagent Pharmaceuticals a99335d0-1e87-4180-bde3-cbb12bf91a52 2023-10-06 Warnings, Adverse reactions Name fallback generic name: DEXMEDETOMIDINE HYDROCHLORIDE Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE Medical Purchasing Solutions, LLC a268e759-9a3e-1d7b-e053-2a95a90a335b 2023-06-01 Warnings, Adverse reactions Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE Dexmedetomidine hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE Medical Purchasing Solutions, LLC a2666c50-3b55-1380-e053-2a95a90aea58 2023-06-01 Warnings, Adverse reactions Name fallback brand name: Dexmedetomidine hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE Medical Purchasing Solutions, LLC 6937235f-ea25-4950-e053-2991aa0a9b74 2023-05-23 Warnings, Adverse reactions Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE Dr.Reddy's Laboratories Inc d174c19d-56f1-4ef4-087c-23c26db8e40b 2022-07-01 Warnings, Adverse reactions Name fallback brand name: DEXMEDETOMIDINE HYDROCHLORIDE generic name: DEXMEDETOMIDINE HYDROCHLORIDE Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE Sun Pharmaceuticals Industries, Inc. 4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa 2018-08-20 Warnings, Adverse reactions Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.