DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2DR REDDYS
02 1ACCORD HLTHCARE
03 1ACTAVIS INC
04 1AM REGENT
05 2AMNEAL
06 2AMNEAL PHARMS CO
07 2BAXTER HLTHCARE CORP
08 2BIOXCEL
09 1CAPLIN
10 3EUGIA PHARMA
11 5FRESENIUS KABI USA
12 3GLAND
13 4HENGRUI PHARMA
14 4HIKMA
15 5HOSPIRA
16 4HQ SPCLT PHARMA
17 1KNACK
18 1MEITHEAL
19 2MILLA PHARMS
20 1MYLAN INSTITUTIONAL
21 2MYLAN LABS LTD
22 3PH HEALTH
23 1PIRAMAL CRITICAL
24 1RISING
25 2SOMERSET
26 3TAGI
27 1TEVA PHARMS USA
28 3WILSHIRE PHARMS INC
29 1ZYDUS PHARMS
01 2FILM;BUCCAL, SUBLINGUAL
02 56INJECTABLE;INJECTION
03 6SOLUTION;INTRAVENOUS
01 3DISCN
02 60RX
03 1Blank
01 57DEXMEDETOMIDINE HYDROCHLORIDE
02 2IGALMI
03 5PRECEDEX
01 52No
02 11Yes
03 1Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AP
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date : 2026-02-25
Application Number : 220315
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AP
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date : 2026-02-25
Application Number : 220315
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date : 2016-06-14
Application Number : 91465
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date : 2015-09-18
Application Number : 201072
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date : 2015-08-20
Application Number : 202126
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date : 1999-12-17
Application Number : 21038
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date : 2013-03-13
Application Number : 21038
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date : 2013-03-13
Application Number : 21038
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Approval Date : 2014-11-14
Application Number : 21038
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
Approval Date : 2020-01-31
Application Number : 21038
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
