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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201687
Company: ENDO OPERATIONS

Products on ANDA 201687

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRETINOIN	TRETINOIN	10MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201687

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2024	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/11/2024	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201687

TRETINOIN

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRETINOIN	TRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB	201687	ENDO OPERATIONS
TRETINOIN	TRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB	208279	GLENMARK PHARMS LTD

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