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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215249
Company: RUBICON RESEARCH

Products on ANDA 215249

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 215249

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/12/2024	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 215249

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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