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FDA Drug NDCs / Labels

16

Labels
NDA Filings Pfizer La , B. Braun , Melinta T

ANDAs (Approved New Drug Applications) Savior Li , Fresenius , Gland Pha , Meitheal , Civica, I , AuroMedic , BluePoint , Hospira, , Amneal Ph , WG Critic , Sandoz In , Daewoong , ACS DOBFA

private labels NovaPlus Premier Intalere Northstar Civica BluePoint Schien (HF or GI)
Vertically Integrated (estimated) savior , acs dob,

FDA Approved Drug Filings

10

Active approvals
Active Approvals / Active Suppliers: ACS DOBFAR , AMNEAL PHA , AUROBINDO , DAEWOONG P , GLAND PHAR , HQ SPCLT P , SAVIOR LIF , PFIZER , B BRAUN ME , REMPEX PHA

FDA Drugs Approvals Returned: MEROPENEM , MEROPENEM; VABORBACTAM

Active Pharmaceutical Ingredients

10

Active API Holders
Companies with Active APIs ACS DOBFAR S , AUROBINDO PH , AURONEXT PHA , SAVIOR LIFET , SHANDONG ANH , SHENZHEN HAI , STERILE INDI , SUMITOMO DAI , SUZHOU HOMES , UNIMARK REME

APIs Returned MEROPENEM , MEROPENEM BULK BLEND , Meropenem USP , MEROPENEM AND SODIUM CARBONATE , MEROPENEM FOR INJECTION , MEROPENEM FOR INJECTION STERIL , MEROPENEM STERILE , MEROPENEM TECHNICAL , MEROPENEM (NON-STERILE DRUG SU , MEROPENEM FOR INJECTION (STERI , MEROPENEM USP (STERILE) , MEROPENEM WITH SODIUM CARBONAT , MEROPENEM FOR INJECTION USP , MEROPENEM TRIHYDRATE STERILE , MEROPENEM TRIHYDRATE NON STERI

Tentative FDA Drug Approvals

0

Tentative Approvals

Pharma Drug Patents

5

Patents
REMPEX PHARMS patent for VABOMERE ( MEROPENEM; VABORBACTAM) for U-2120: TREATMENT OF PATIENTS 18 YEARS OF AGE AND OLDER WITH COMPLICATED URINARY TRACT INFECTIONS CAUSED BY SUSCEPTIBLE MICROORGANISMS with EXPIRY of 2031-08-08

REMPEX PHARMS patent for VABOMERE ( MEROPENEM; VABORBACTAM) for U-2490: TREATMENT OF COMPLICATED URINARY TRACT INFECTION (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, AND ENTEROBACTER CLOACAE SPECIES COMPLEX with EXPIRY of 2031-08-08

REMPEX PHARMS patent for VABOMERE ( MEROPENEM; VABORBACTAM) for U-2490: TREATMENT OF COMPLICATED URINARY TRACT INFECTION (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, AND ENTEROBACTER CLOACAE SPECIES COMPLEX with EXPIRY of 2031-08-08

REMPEX PHARMS patent for VABOMERE ( MEROPENEM; VABORBACTAM) for : with EXPIRY of 2031-08-08

REMPEX PHARMS patent for VABOMERE ( MEROPENEM; VABORBACTAM) for : with EXPIRY of 2031-08-17


FDA Drug Exclusivity

0

Exclusivities

Federal Supply Schedule Pricing

4

Vendors on FSS
Companies on Federal Supply Schedule Golden State Medical Supply, Inc. , Melinta Therapeutics, Inc. , Pfizer, Inc. , Fresenius Kabi, LLC

Pharmaceutical Drugs on Federal Supply Schedule MEROPENEM 1GM/VIL INJ , MEROPENEM 500MG/VIL INJ , MEROPENEM 1GM/VABORBACTAM 1GM/VIAL INJ,PWDR , MEROPENEM 1GM/VIL,INJ , MEROPENEM 500MG/VIL,INJ

Shared Drug Filings

3

Filings
See more under details

FDA Drug Shortage

0

Listed
Currently in Shortage 0
Drug Shortage Resolved 0
Drug to be Discontinued 0

Paragraph IV Drug Files

0

Listings

Compounded Presentations

0

Total Returned
Compounders Returned

National Average Drug Acquisition Cost

0

FDA Drugs
List of approved drugs with a NADAC

Search meropenem FDA drug labels to production site status and API suppliers

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See some of the popular searches here. Some are large and may take a while to load. These popular searches include Company Search Pfizer, Company Search Fresenius and Drug Search Sugammadex

It is time to stop searching drugs FDA labels for meropenem

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Let's be honest, information on FDA approved drugs is extremely disparate. Upon FDA drug approval, details on FDA labels are sent to multiple agencies who publish different information. Not to mention, all the competitive intelligence drug information you are seeking is redacted and located in different databases.

Wizmed has taken pharmaceutical research to the next level.


Wizmed is able to read FDA drug labels from sources like the FDA orange book and openFDA and extract key information not in databased such as private labels and FDA drug shortages. At the same time, the team has developed golden keys to match up pharma NDCs with FDA communication letters regarding that drug.

Did you know that sometimes those letters even include secrets like drug expiry shelf life and the API suppliers?


Wizmed does and links up the FDA letters by drug NDC and you can access it in the details of a drug page, See Example . If that was not enough for your to use Wizmed. We even use fuzzy lookups to make estimations on which FDA registered locations are making active pharmaceutical ingredients to drive some insight into where your pharmaceuticals are made.

Did you know that sometimes those letters even include secrets like drug expiry shelf life and the API suppliers?


Wizmed does and links up the FDA letters by drug NDC and you can access it in the details of a drug page, See Example . If that was not enough for your to use Wizmed. We even use fuzzy lookups to make estimations on which FDA registered locations are making active pharmaceutical ingredients to drive some insight into where your pharmaceuticals are made.

Data Sources 200,000 records

Dailymed - Continuously Updates
OpenFDA - Continuous Updates
Federal Supply Schedule Pricing - Daily
Drugs@FDA - Weekly
Orange Book - Weekly
483s - Weekly
Warning Letters - Weekly
Drug Patents - Weekly
FDA Inspections - Weekly
DMF files - Quarterly
Data dependant on timing of updates to source data. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.

Need help understanding all the information? Feel free to contact us or view our video tutorials. WIZMED sources is data from the FDA, Dailymed, Medicaid data and other data sources and uses calculations to attempt to align datasets. The data feeds may run night, weekly and/or quarterly depending on data source. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.