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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040560
Company: NOSTRUM LABS INC

Products on ANDA 040560

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE; ORAL	Prescription	None	No	No
THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	Yes
THEOPHYLLINE	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040560

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2006	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
11/20/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040560

THEOPHYLLINE

TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090355	GLENMARK PHARMS LTD
THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	040560	NOSTRUM LABS INC
THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	040086	RHODES PHARMS

TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THEOPHYLLINE	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090355	GLENMARK PHARMS LTD
THEOPHYLLINE	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	040560	NOSTRUM LABS INC
THEOPHYLLINE	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	040086	RHODES PHARMS

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