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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040419
Company: SPECGX LLC

REMS

Products on ANDA 040419

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET;ORAL	Prescription	AA	No	Yes
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Prescription	AA	No	Yes
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040419

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40419ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/07/2019	SUPPL-26	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/20/2018	SUPPL-25	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-24	REMS - PROPOSAL - D-N-A		Label is not available on this site.
04/06/2018	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/06/2018	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/18/2013	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
05/10/2013	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
06/22/2011	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/21/2008	SUPPL-11	Labeling		Label is not available on this site.
11/30/2007	SUPPL-10	Labeling		Label is not available on this site.
12/13/2002	SUPPL-4	Labeling		Label is not available on this site.
12/13/2002	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
12/13/2002	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/11/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 040419

ACETAMINOPHEN AND CODEINE PHOSPHATE

TABLET;ORAL; 300MG;15MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET;ORAL	Prescription	No	AA	202800	AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET;ORAL	Prescription	No	AA	212418	ELITE LABS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET;ORAL	Prescription	No	AA	040419	SPECGX LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET;ORAL	Prescription	No	AA	089990	STRIDES PHARMA
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET;ORAL	Prescription	No	AA	211610	WES PHARMA INC

TABLET;ORAL; 300MG;30MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Prescription	No	AA	040779	AMNEAL PHARMS NY
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Prescription	No	AA	202800	AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Prescription	No	AA	212418	ELITE LABS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Prescription	No	AA	040419	SPECGX LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Prescription	No	AA	089805	STRIDES PHARMA
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Prescription	No	AA	211610	WES PHARMA INC

TABLET;ORAL; 300MG;60MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET;ORAL	Prescription	No	AA	202800	AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET;ORAL	Prescription	No	AA	212418	ELITE LABS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET;ORAL	Prescription	No	AA	040419	SPECGX LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET;ORAL	Prescription	No	AA	089828	STRIDES PHARMA
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET;ORAL	Prescription	No	AA	087083	SUN PHARM INDS LTD
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET;ORAL	Prescription	No	AA	211610	WES PHARMA INC

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