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Consolidated Pharma Data Platform, see what is new over the past 30 days.

WIZMED sources is data from the FDA, Dailymed, Medicaid data and other data sources. The data feeds 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.

3 FDA CDER quality inspections posted in last 60 days

This is updated weekly with the latest FDA inspections.

Company City Country Inspection End Date Project Area Classification
GK Cosmetic Co., Ltd Namdong KR 2019-07-19 Drug Quality Assurance VAI
Airgas USA, LLC La Porte US 2019-07-31 Drug Quality Assurance NAI
Paket Corp Chicago US 2019-08-06 Drug Quality Assurance VAI

WIZMED searches for the latest public 483s weekly.

MFG Country Date Link
Ipca Laboratories Limited India 2019-08-23
Dr. Reddy's Laboratories Ltd. India 2019-08-20
Shilpa Medicare Limited India 2019-07-26
Cipla Ltd. Virgonagar Site India 2019-07-19

Latest FDA warning letters below, this is updated weekly with the latest FDA warning letters.

Company Issue Date Office Link
JUUL Labs, Inc. 2019-09-09 Center for Tobacco Products
Peggy Lawton Kitchen 2019-08-29 Division of Human and Animal Food Operations East I
Hangzhou Badi Daily 2019-08-29 Center for Drug Evaluation and Research
Kevin Klug 2019-08-28 Office of Human and Animal Food-West Division II
True Vape USA 2019-08-22 Center for Tobacco Products
Agroson's LLC 2019-08-26 Division of Northeast Imports
Stemell Inc 2019-08-28 Office of Biological Products Operations - Division II
Absonutrix, LLC 2019-08-26 Division of Human and Animal Food Operations East III
Sportron Internation 2019-08-23 Office of Human and Animal Food West Division 3
Mountain Vaporz LLC 2019-08-22 Center for Tobacco Products
Shree Datt Aquacultu 2019-08-22 Center for Food Safety and Applied Nutrition
Polimeros y Servicio 2019-08-22 Center for Drug Evaluation and Research
Comercial Mares de C 2019-08-19 Center for Food Safety and Applied Nutrition
Haw Par Healthcare L 2019-08-19 Center for Drug Evaluation and Research

Monitor latest FDA approvals

MFG Route Drug Strength NDCs Type Approval Date PI Labels
GLENMARK PHARMS topical clobetasol propionate 0.05% ANDA 2019-09-09
INVENTIA HLTHCA oral tolterodine tartrate 2MG ANDA 2019-08-19
INVENTIA HLTHCA oral tolterodine tartrate 4MG ANDA 2019-08-19
NOVITIUM PHARMA oral nitisinone 2MG ANDA 2019-08-26
NOVITIUM PHARMA oral nitisinone 5MG ANDA 2019-08-26
NOVITIUM PHARMA oral nitisinone 10MG ANDA 2019-08-26
AGNITIO oral triamterene 50MG ANDA 2019-08-19
AGNITIO oral triamterene 100MG ANDA 2019-08-19
PHARM ASSOC oral methadone hydrochloride 10MG/ML ANDA 2019-08-22
GLENMARK PHARMS topical pimecrolimus 1% ANDA 2019-08-29
SUN PHARM oral metformin hydrochloride 500MG/5ML NDA 2019-08-29
TARO topical azelaic acid 15% ANDA 2019-08-23
PERRIGO ISRAEL topical benzoyl peroxide; clindamycin phosphate 2.5%;EQ 1.2% BASE ANDA 2019-09-09
TARO topical benzoyl peroxide; clindamycin phosphate 2.5%;EQ 1.2% BASE ANDA 2019-08-19
TOLMAR topical benzoyl peroxide; clindamycin phosphate 2.5%;EQ 1.2% BASE ANDA 2019-08-19
GLENMARK PHARMS intramuscular fulvestrant 50MG/ML ANDA 2019-08-22
MAIA PHARMS INC intrathecal baclofen 0.5MG/ML ANDA 2019-09-11
MAIA PHARMS INC intrathecal baclofen 2MG/ML ANDA 2019-09-11
MSN LABS PVT LT intravenous decitabine 50MG/VIAL ANDA 2019-08-28
SUN PHARM iv (infusion) pantoprazole sodium EQ 40MG BASE/VIAL ANDA 2019-08-19
APOTEX INC topical acyclovir 5% ANDA 2019-09-06
GILEAD SCIENCES oral ledipasvir; sofosbuvir 33.75MG;150MG/PACKET NDA 2019-08-28
GILEAD SCIENCES oral ledipasvir; sofosbuvir 45MG;200MG/PACKET NDA 2019-08-28
GILEAD SCIENCES oral sofosbuvir 150MG/PACKET NDA 2019-08-28
GILEAD SCIENCES oral sofosbuvir 200MG/PACKET NDA 2019-08-28
DR REDDYS intravenous carfilzomib 60MG/VIAL ANDA 2019-09-09
JIANGSU HENGRUI intravenous daptomycin 500MG/VIAL ANDA 2019-08-22
APOTEX INC intravenous fosaprepitant dimeglumine EQ 150MG BASE/VIAL ANDA 2019-09-05
BAXTER HLTHCARE intravenous fosaprepitant dimeglumine EQ 150MG BASE/VIAL ANDA 2019-09-05
BE PHARMS intravenous fosaprepitant dimeglumine EQ 150MG BASE/VIAL ANDA 2019-09-05
LUPIN LTD intravenous fosaprepitant dimeglumine EQ 150MG BASE/VIAL ANDA 2019-09-05
MSN LABS PVT LT intravenous fosaprepitant dimeglumine EQ 150MG BASE/VIAL ANDA 2019-09-05
MYLAN LABS LTD intravenous fosaprepitant dimeglumine EQ 115MG BASE/VIAL ANDA 2019-09-05
MYLAN LABS LTD intravenous fosaprepitant dimeglumine EQ 150MG BASE/VIAL ANDA 2019-09-05
SUNGEN PHARMA intravenous fosaprepitant dimeglumine EQ 150MG BASE/VIAL ANDA 2019-09-05
NANJING KING-FR intravenous levoleucovorin calcium EQ 50MG BASE/VIAL ANDA 2019-08-22
PAR PHARM INC oral sapropterin dihydrochloride 100MG/PACKET ANDA 2019-08-20
PAR PHARM INC oral sapropterin dihydrochloride 500MG/PACKET ANDA 2019-08-20
AUROBINDO PHARM ophthalmic latanoprost 0.01% ANDA 2019-09-03
MICRO LABS ophthalmic tafluprost 0.00% ANDA 2019-08-19
AMNEAL PHARMS C otic ofloxacin 0.30% ANDA 2019-08-30
TEVA PHARMS USA intramuscular fulvestrant 250MG/5ML (50MG/ML) NDA 2019-08-19
UIHC PET IMAGIN intravenous gallium dotatoc ga-68 0.5-4mCi/ML NDA 2019-08-21
NABRIVA intravenous lefamulin acetate EQ 150MG BASE/15ML (EQ 10MG BASE/ML) NDA 2019-08-19
HI TECH nasal azelastine hydrochloride EQ 0.1876MG BASE/SPRAY ANDA 2019-08-23
QUAGEN oral albuterol sulfate EQ 2MG BASE/5ML ANDA 2019-09-06
AMNEAL PHARMS L oral aminocaproic acid 1.25GM/5ML ANDA 2019-08-23
SINOTHERAPEUTIC oral posaconazole 100MG ANDA 2019-08-21
ZHEJIANG JUTAI oral bupropion hydrochloride 300MG ANDA 2019-09-05
ASCENT PHARMS I oral methylphenidate hydrochloride 18MG ANDA 2019-09-03
ASCENT PHARMS I oral methylphenidate hydrochloride 27MG ANDA 2019-09-03
ASCENT PHARMS I oral methylphenidate hydrochloride 36MG ANDA 2019-09-03
ASCENT PHARMS I oral methylphenidate hydrochloride 54MG ANDA 2019-09-03
CADILA oral ranolazine 1GM ANDA 2019-08-19
CADILA oral ranolazine 500MG ANDA 2019-08-19
CADILA PHARMS L oral venlafaxine hydrochloride EQ 75MG BASE ANDA 2019-08-29
CADILA PHARMS L oral venlafaxine hydrochloride EQ 150MG BASE ANDA 2019-08-29
CADILA PHARMS L oral venlafaxine hydrochloride EQ 225MG BASE ANDA 2019-08-29
ELITE LABS INC oral acetaminophen; codeine phosphate 300MG;15MG ANDA 2019-09-10
ELITE LABS INC oral acetaminophen; codeine phosphate 300MG;30MG ANDA 2019-09-10
ELITE LABS INC oral acetaminophen; codeine phosphate 300MG;60MG ANDA 2019-09-10
ALKEM LABS LTD oral clobazam 10MG ANDA 2019-09-06
ALKEM LABS LTD oral clobazam 20MG ANDA 2019-09-06
DR REDDYS oral colchicine 0.6MG ANDA 2019-09-06
LUPIN LTD oral ethacrynic acid 25MG ANDA 2019-09-06
SCIEGEN PHARMS oral ethacrynic acid 25MG ANDA 2019-08-27
APPCO PHARMA LL oral fenofibrate 54MG ANDA 2019-09-06
APPCO PHARMA LL oral fenofibrate 160MG ANDA 2019-09-06
EMCURE PHARMS L oral lurasidone hydrochloride 20MG ANDA 2019-09-04
EMCURE PHARMS L oral lurasidone hydrochloride 40MG ANDA 2019-09-04
EMCURE PHARMS L oral lurasidone hydrochloride 60MG ANDA 2019-09-04
EMCURE PHARMS L oral lurasidone hydrochloride 80MG ANDA 2019-09-04
RUBICON oral midodrine hydrochloride 2.5MG ANDA 2019-08-19
RUBICON oral midodrine hydrochloride 5MG ANDA 2019-08-19
RUBICON oral midodrine hydrochloride 10MG ANDA 2019-08-19
NEXGEN PHARMA I oral nabumetone 1GM ANDA 2019-08-30
NEXGEN PHARMA I oral nabumetone 500MG ANDA 2019-08-30
NEXGEN PHARMA I oral nabumetone 750MG ANDA 2019-08-30
KYOWA KIRIN oral istradefylline 20MG NDA 2019-08-27
KYOWA KIRIN oral istradefylline 40MG NDA 2019-08-27
UNICHEM LABS LT oral solifenacin succinate 5MG ANDA 2019-08-27
UNICHEM LABS LT oral solifenacin succinate 10MG ANDA 2019-08-27
NABRIVA oral lefamulin acetate EQ 600MG BASE NDA 2019-08-19

List of new API DMFs (drug master files) from FDA which is updated quarterly

Company Submit Date Subject
R L FINE CHEM P 2019-06-26 CHLORDIAZEPOXIDE
OLON SPA 2019-06-27 LENVATINIB MESYLATE
FARMABIOS SPA 2019-06-26 EPOXIDE DESOXYMETASONE (INTERMEDIATE)
AUROBINDO PHARM 2019-06-26 CARIPRAZINE HYDROCHLORIDE PREMIX
LAURUS LABS LTD 2019-06-25 LOPINAVIR USP
MSN LABORATORIE 2019-06-28 BUMETANIDE USP
KAWMAN PHARMA 2019-06-21 MUPIROCIN CALCIUM USP
SUN PHARMACEUTI 2019-06-28 VALSARTAN USP
ADARE PHARMACEU 2019-06-20 APAP MICROCAPS

Abriged, not to be used by medical professionals, updated daily from the FDA website

Company Drug Reason NDCs Date Lot Quantity

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.