Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085186
Company: NOSTRUM LABS INC

Products on ANDA 085186

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELIXOPHYLLIN	THEOPHYLLINE	80MG/15ML	SOLUTION, ELIXIR;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085186

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/1979	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
06/26/2014	SUPPL-25	Labeling-Container/Carton Labels		Label is not available on this site.
02/18/1999	SUPPL-18	Labeling		Label is not available on this site.
02/22/1993	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/17/1989	SUPPL-13	Labeling		Label is not available on this site.
02/06/1987	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/06/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/24/1982	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/05/1982	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 085186

ELIXOPHYLLIN

SOLUTION, ELIXIR;ORAL; 80MG/15ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELIXOPHYLLIN	THEOPHYLLINE	80MG/15ML	SOLUTION, ELIXIR;ORAL	Prescription	Yes	AA	085186	NOSTRUM LABS INC
THEOPHYLLINE	THEOPHYLLINE	80MG/15ML	SOLUTION, ELIXIR;ORAL	Prescription	No	AA	206344	PHARM ASSOC