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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214496
Company: EPIC PHARMA LLC

Products on ANDA 214496

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214496

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214496

PREGABALIN

TABLET, EXTENDED RELEASE;ORAL; 82.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LYRICA CR	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	209501	UPJOHN
PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214496	EPIC PHARMA LLC
PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213226	MSN
PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215249	RUBICON RESEARCH

TABLET, EXTENDED RELEASE;ORAL; 165MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LYRICA CR	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	209501	UPJOHN
PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214496	EPIC PHARMA LLC
PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213226	MSN
PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215249	RUBICON RESEARCH

TABLET, EXTENDED RELEASE;ORAL; 330MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LYRICA CR	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	209501	UPJOHN
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217857	AIPING PHARM INC
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214496	EPIC PHARMA LLC
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213226	MSN
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215249	RUBICON RESEARCH

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