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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091182
Company: KENTON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription AA No No
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription AA 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
02/03/2014 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

02/23/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

GLYCOPYRROLATE

TABLET;ORAL; 1MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 203657 ALEMBIC LABS
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 202675 AUROLIFE PHARMA LLC
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 040847 DR REDDYS LABS LTD
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 207201 HERITAGE PHARMS INC
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 091182 KENTON
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 090195 LEADING
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 091413 NATCO
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 090020 OXFORD PHARMS
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 040653 PAR PHARM
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 040821 RISING
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 040844 SUN PHARM INDS LTD
ROBINUL GLYCOPYRROLATE 1MG TABLET;ORAL Prescription Yes AA 012827 CASPER PHARMA LLC

TABLET;ORAL; 2MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 203657 ALEMBIC LABS
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 202675 AUROLIFE PHARMA LLC
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 040847 DR REDDYS LABS LTD
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 207201 HERITAGE PHARMS INC
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 091182 KENTON
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 090195 LEADING
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 091413 NATCO
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 090020 OXFORD PHARMS
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 040653 PAR PHARM
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 040821 RISING
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 040844 SUN PHARM INDS LTD
ROBINUL FORTE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription Yes AA 012827 CASPER PHARMA LLC
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