Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206697
Company: AMNEAL

Products on ANDA 206697

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXENATIDE SYNTHETIC	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	AP	No	No
EXENATIDE SYNTHETIC	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206697

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206697

EXENATIDE SYNTHETIC

INJECTABLE;SUBCUTANEOUS; 300MCG/1.2ML (250MCG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BYETTA	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	Yes	AP	021773	ASTRAZENECA AB
EXENATIDE SYNTHETIC	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	206697	AMNEAL

INJECTABLE;SUBCUTANEOUS; 600MCG/2.4ML (250MCG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BYETTA	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	Yes	AP	021773	ASTRAZENECA AB
EXENATIDE SYNTHETIC	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	206697	AMNEAL