An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204072
Company: TIANJIN TIANYAO

Products on ANDA 204072

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204072

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2018	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204072

METHYLPREDNISOLONE

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEDROL	METHYLPREDNISOLONE	4MG	TABLET;ORAL	Prescription	Yes	AB	011153	PFIZER
METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET;ORAL	Prescription	No	AB	040183	ENDO OPERATIONS
METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET;ORAL	Prescription	No	AB	040189	JUBILANT CADISTA
METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET;ORAL	Prescription	No	AB	040194	SANDOZ
METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET;ORAL	Prescription	No	AB	204072	TIANJIN TIANYAO
METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET;ORAL	Prescription	No	AB	040232	WATSON LABS
METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET;ORAL	Prescription	No	AB	206751	ZYDUS PHARMS

Top