U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089335
Company: AM REGENT

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
09/04/2019 SUPPL-23 Labeling-Package Insert

Label is not available on this site.
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 213238 ACCORD HLTHCARE
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 214635 ALEMBIC
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 089335 AM REGENT
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 208973 AMNEAL
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 215333 AMNEAL
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 210246 APOTEX
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 212871 ASPEN
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 211705 CAPLIN
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 212612 GLAND PHARMA LTD
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 090963 HIKMA FARMACEUTICA
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 212802 MEITHEAL
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 212591 NIVAGEN PHARMS INC
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 210083 SAGENT
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 211334 SANDOZ
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 207639 SOMERSET THERAPS LLC
GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 212227 XIROMED
Back to Top