Labels - Marketing Product 30
Approvals - Approved FDA Filings 23
API - Active Pharmaceutical Ingredients Filings 12
Tentative Approvals 1
The marketing companies and product returned from the search dexmedetomidine include ACCORD HE ACTAVIS I AKORN AMNEAL PH ATHENEX P AUROMEDIC BAXTER HE BIOXCEL T CADILA HE CIVICA, I DR.REDDY' FRESENIUS GENERAL I GLAND PHA HENRY SCH HIKMA PHA HOSPIRA, MEDICAL P MEITHEAL MYLAN INS PAR PHARM PIRAMAL C PRECISION SANDOZ IN SLAYBACK SUN PHARM TAGI PHAR TEVA PHAR WG CRITIC ZYDUS PHA based on the returned terms: DEXMEDETOMIDINE DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE DEXMEDETOMIDINE HCL DEXMEDETOMIDINE HYDROCHLORIDE
Go To More Details on dexmedetomidine Marketers Go To More Details on dexmedetomidine MarketersActive FDA approvals for the search dexmedetomidine exist for ACCORD HLT ACTAVIS IN AKORN AMNEAL PHA BAXTER HLT BIOXCEL EUGIA PHAR FRESENIUS GLAND GLAND PHAR HIKMA HOSPIRA HQ SPCLT P JIANGSU PH MEITHEAL MYLAN INST MYLAN LABS PAR STERIL SANDOZ INC SLAYBACK P TAGI TEVA PHARM ZYDUS PHAR based on the returned terms: DEXMEDETOMIDINE HYDROCHLORIDE
Go to FDA Approvals for dexmedetomidineAPIs filings returned based on the search term dexmedetomidine are ASYMCHEM LAB CHEMWERTH IN EDMOND PHARM EMCURE PHARM FERMION OY GLAND PHARMA HUBEI BIOCAU INTERQUIM SA JIANGSU HENG MOEHS IBERIC RELIABLE BIO STERLING WIS based on the returned terms: DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HCI DEXMEDETOMIDINE HCL DEXMEDETOMIDINE DRUG SUBSTANCE
Go to API Details for dexmedetomidine Go to API Details for dexmedetomidineTentative approvals are typically a filing that is ready to approve but waiting for a patent or exclusivity period to expire prior to approval. Information on tentatively approved drug can inform pharma companies of future entrants that may impact thier go to market staregy or inform business development experts of companies that may be looking for a partner to bring a tentatively approved drug to the market.
We where able to find the following tentative approvals based on the search dexmedetomidine . FRESENIUS KABI USA, DEXMEDETOMIDINE HYDROCHLORIDE, EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTIONWe have been able to locate the private label and GPO suppliers for the following highlighted labels. Click on the details to see the private label supplier
BluePoint Civica Intalere Northstar NovaPlus Premier Schein (HF or GI)
Vertically integrated analysis is completed by searchong for companies with the FDA approved drug filings and an API (Drug Master Filings) on record. That list includes... gland p
FDA Shortages - Listings on FDA Shortage List 14
Recalls - Recalls on product (abridged) 3
483s - Drug Mentioned in 483s 4
Compounders - Compounders Making This Drug 3
How Made - Report on Manufacturing Process 2
There are a total of 14 drug shortage listings for dexmedetomidine . Of those listings 14 are listed as current drug shortages while 0 are listed as resolved and 0 listed as to be discontinued.
Go To dexmedetomidine Drug Shortage Details Go To dexmedetomidine Drug Shortage DetailsRecalling firms and dates include MCKESSON MEDICAL-SURGICAL INC. CORPORATE OFFICE, 20220615 FRESENIUS KABI USA, LLC, 20200902 FRESENIUS KABI USA, LLC, 20201216
FDA 483 forms are the forms to close out inspections and they note any FDA observations. Wizmed performs word searched of common words and drug names within 483s on file. We were able to idendifty the following 483s that mention this drug from HOSPIRA HOSPIRA INC, A PFIZER COMPANY HOSPIRA INC. HOSPIRA INC. A PFIZER COMPANY
See the 483s for dexmedetomidine See the 483s for dexmedetomidineCompounders, often reffered to as 503b compounders, prepare and modify drugs to be in a more final form for use by health care practitioners and patients. We were able to locate the following compounders for this search. QUVA PHARMA(079 NEPHRON STERILE DENVER SOLUTION
Go To Compounders for dexmedetomidine Go To Compounders for dexmedetomidineOne method to access manufactuing process is to use filings out of Europe which publish manufacturing data. filings we were able to locate are for the following company(s) Orion Corporation Accord Healthcare S.L.U.
Go To Manufacturing Reports Go To Manufacturing ReportsPatents - Drug Patents 15
Exclusivity - FDA Exclusivity 0
PIV - Paragraph IV Drug Files 3
We were able to locate the following drug patents which you can click to see the drug patent details. Patent 8455527, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-01-04 Patent 8648106, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-01-04 Patent 9616049, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-01-04 Patent 8242158, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-01-04 Patent 10016396, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-01-04 Patent 9320712, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-01-04 Patent 9649296, HQ SPCLT PHARMA, DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE, 2036-04-20 Patent 8338470, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-01-04 Patent 9717796, HQ SPCLT PHARMA, DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE, 2036-04-20 Patent 8648106*PED, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-07-04 Patent 8242158*PED, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-07-04 Patent 8455527*PED, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-07-04 Patent 8338470*PED, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-07-04 Patent 9320712*PED, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-07-04 Patent 9616049*PED, HOSPIRA, PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, 2032-07-04
The FDA offers drug exclusivities for products such as Orphan Drug Exclusivity (ODE) – 7 years, New Chemical Entity Exclusivity (NCE) – 5 years, Generating Antibiotic Incentives Now (GAIN) Exclusivity – 5 years added to certain exclusivities, New Clinical Investigation Exclusivity – 3 years, Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity, Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only), Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only).
There were no FDA exclusivities located for the serach dexmedetomidinePrecedex 21038 (Dexmedetomidine Injection 100 mcg/mL) had a patent submission date of 4/8/2009 and has a current 180 day status of _ Eligible. There are _1 ANDAs submitted. The date of the last PIV qualifying patent is _ 3/31/2019. The date of the first applicant approval is _6/14/2016.
Shared Filings 10
GPO/Private Labels Identified 3
We have been able to locate that there are 10 shared filings for the search dexmedetomidine
Go To Shared Filings for dexmedetomidine Marketers Go To Shared Filings for dexmedetomidine MarketersWe have been able to locate the private label and GPO suppliers for the following highlighted labels. Click on the details to see the private label supplier
BluePoint Civica Intalere Northstar NovaPlus Premier Schein (HF or GI)
FSS - Federal Supply Schedule Pricing 7
NADAC - National Drug Acquisition Cost 0
Federal supply schedule drug pricing sets the pricing paid by the many government entities. The data is pulled daily and we have it for Baxter Healthcare Corporation Fresenius Kabi, LLC Golden State Medical Supply, Inc. Hospira Worldwide, LLC Mylan Institutional LLC Par Pharmaceutical, Inc. dba Par Pharmaceutical WG Critical Care, LLC
Go To FSS Details on dexmedetomidine MarketersThe National Average Drug Acquisition Cost or NADAC sets some key reimbursement rates of drugs.
We did not have any NADAC's for the search dexmedetomidine .
Advertising - Available Relevant Ads 0
Warnings - Product Warning and Precautions Coming soon
We have 0 promotional materials for the search dexmedetomidine . Promotional ads are highly regulated and based off of OpenFDA this product has specific warnings and risks called out.
We have no pharmaceutical ads on file for the search dexmedetomidine .
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