Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205318
Company: TELIGENT PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription AT No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/01/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205318Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2018 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/17/2017 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

LIDOCAINE

OINTMENT;TOPICAL; 5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 211019 ACP NIMBLE
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 211469 ALEOR DERMACEUTICALS
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 207810 ALKEM LABS LTD
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 206297 AMNEAL PHARMS
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 080198 FOUGERA PHARMS INC
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 206498 GLENMARK PHARMS LTD
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 208604 RICONPHARMA LLC
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 040911 SEPTODONT INC
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 210958 STRIDES PHARMA
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 086724 TARO
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 205318 TELIGENT PHARMA INC
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 210256 TEVA PHARMS USA
LIDOCAINE LIDOCAINE 5% OINTMENT;TOPICAL Prescription No AT 208822 VITRUVIAS THERAP

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