Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207623
Company: ALKEM LABS LTD

Products on ANDA 207623

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREGABALIN	PREGABALIN	20MG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207623

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/19/2019	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
06/26/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207623

PREGABALIN

SOLUTION;ORAL; 20MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LYRICA	PREGABALIN	20MG/ML	SOLUTION;ORAL	Prescription	Yes	AA	022488	UPJOHN
PREGABALIN	PREGABALIN	20MG/ML	SOLUTION;ORAL	Prescription	No	AA	207623	ALKEM LABS LTD
PREGABALIN	PREGABALIN	20MG/ML	SOLUTION;ORAL	Prescription	No	AA	212604	ANDA REPOSITORY