Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207639
Company: SOMERSET THERAPS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription AP 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
06/23/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207639Orig1s000ltr.pdf

GLYCOPYRROLATE

INJECTABLE;INJECTION; 0.2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 208973 AMNEAL PHARMS CO
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 210244 AUROBINDO PHARMA LTD
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 209024 FRESENIUS KABI USA
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 209328 FRESENIUS KABI USA
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 090963 HIKMA FARMACEUTICA
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 089335 LUITPOLD
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 210842 PIRAMAL CRITICAL
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 210927 PRINSTON INC
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 207639 SOMERSET THERAPS LLC

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