Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209024
Company: FRESENIUS KABI USA

Products on ANDA 209024

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209024

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209024

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	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
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	212871	OMNIVIUM PHARMS
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
ROBINUL	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017558	HIKMA