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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040189
Company: JUBILANT CADISTA

Products on ANDA 040189

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET;ORAL	Prescription	AB	No	No
METHYLPREDNISOLONE	METHYLPREDNISOLONE	8MG	TABLET;ORAL	Prescription	AB	No	No
METHYLPREDNISOLONE	METHYLPREDNISOLONE	16MG	TABLET;ORAL	Prescription	AB	No	No
METHYLPREDNISOLONE	METHYLPREDNISOLONE	32MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040189

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1997	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
07/19/2007	SUPPL-10	Labeling		Label is not available on this site.
07/14/2003	SUPPL-6	Labeling		Label is not available on this site.
09/05/2002	SUPPL-5	Labeling		Label is not available on this site.
09/05/2002	SUPPL-4	Labeling		Label is not available on this site.
03/19/1998	SUPPL-2	Labeling		Label is not available on this site.
03/19/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 040189

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

TABLET;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEDROL	METHYLPREDNISOLONE	8MG	TABLET;ORAL	Prescription	Yes	AB	011153	PFIZER
METHYLPREDNISOLONE	METHYLPREDNISOLONE	8MG	TABLET;ORAL	Prescription	No	AB	040189	JUBILANT CADISTA
METHYLPREDNISOLONE	METHYLPREDNISOLONE	8MG	TABLET;ORAL	Prescription	No	AB	206751	ZYDUS PHARMS

TABLET;ORAL; 16MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEDROL	METHYLPREDNISOLONE	16MG	TABLET;ORAL	Prescription	Yes	AB	011153	PFIZER
METHYLPREDNISOLONE	METHYLPREDNISOLONE	16MG	TABLET;ORAL	Prescription	No	AB	040189	JUBILANT CADISTA
METHYLPREDNISOLONE	METHYLPREDNISOLONE	16MG	TABLET;ORAL	Prescription	No	AB	206751	ZYDUS PHARMS

TABLET;ORAL; 32MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEDROL	METHYLPREDNISOLONE	32MG	TABLET;ORAL	Prescription	Yes	AB	011153	PFIZER
METHYLPREDNISOLONE	METHYLPREDNISOLONE	32MG	TABLET;ORAL	Prescription	No	AB	040189	JUBILANT CADISTA
METHYLPREDNISOLONE	METHYLPREDNISOLONE	32MG	TABLET;ORAL	Prescription	No	AB	206751	ZYDUS PHARMS

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