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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211555
Company: EYWA PHARMA

Products on ANDA 211555

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	BX	No	No
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	BX	No	No
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211555

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2019	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
11/30/2021	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
05/06/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211555

BACLOFEN

There are no Therapeutic Equivalents.

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