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Abbreviated New Drug Application (ANDA): 212467
Company: SUVEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYCOPYRROLATE GLYCOPYRROLATE 1MG/5ML SOLUTION;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
07/05/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212467Orig1s000TA_ltr.pdf

GLYCOPYRROLATE

SOLUTION;ORAL; 1MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CUVPOSA GLYCOPYRROLATE 1MG/5ML SOLUTION;ORAL Prescription Yes AA 022571 MERZ PHARMS
GLYCOPYRROLATE GLYCOPYRROLATE 1MG/5ML SOLUTION;ORAL Prescription No AA 213698 ANNORA PHARMA
GLYCOPYRROLATE GLYCOPYRROLATE 1MG/5ML SOLUTION;ORAL Prescription No AA 204438 PAR PHARM INC
GLYCOPYRROLATE GLYCOPYRROLATE 1MG/5ML SOLUTION;ORAL Prescription No AA 212467 SUVEN PHARMS
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