Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203046
Company: LANNETT CO INC

• REMS

Products on ANDA 203046

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CODEINE SULFATE	CODEINE SULFATE	15MG	TABLET;ORAL	Prescription	AB	No	No
CODEINE SULFATE	CODEINE SULFATE	30MG	TABLET;ORAL	Prescription	AB	No	No
CODEINE SULFATE	CODEINE SULFATE	60MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203046

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2014	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
09/18/2018	SUPPL-7	REMS - PROPOSAL - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 203046

CODEINE SULFATE

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CODEINE SULFATE	CODEINE SULFATE	15MG	TABLET;ORAL	Prescription	Yes	AB	022402	HIKMA
CODEINE SULFATE	CODEINE SULFATE	15MG	TABLET;ORAL	Prescription	No	AB	203046	LANNETT CO INC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CODEINE SULFATE	CODEINE SULFATE	30MG	TABLET;ORAL	Prescription	Yes	AB	022402	HIKMA
CODEINE SULFATE	CODEINE SULFATE	30MG	TABLET;ORAL	Prescription	No	AB	203046	LANNETT CO INC

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CODEINE SULFATE	CODEINE SULFATE	60MG	TABLET;ORAL	Prescription	Yes	AB	022402	HIKMA
CODEINE SULFATE	CODEINE SULFATE	60MG	TABLET;ORAL	Prescription	No	AB	203046	LANNETT CO INC