Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089335
Company: LUITPOLD
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
07/23/1986 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
09/26/2006 SUPPL-15 Labeling

Label is not available on this site.

06/23/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/28/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/09/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/15/1990 SUPPL-7 Labeling

Label is not available on this site.

01/25/1990 SUPPL-6 Labeling

Label is not available on this site.

03/04/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/09/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/09/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/08/1988 SUPPL-2 Labeling

Label is not available on this site.

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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