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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089990
Company: STRIDES PHARMA

REMS

Products on ANDA 089990

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089990

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/1988	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
10/31/2024	SUPPL-36	REMS - MODIFIED - D-N-A		Label is not available on this site.
03/10/2025	SUPPL-35	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
10/07/2019	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
10/07/2019	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-26	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/29/2017	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
10/18/2013	SUPPL-15	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-8	Labeling-Package Insert		Label is not available on this site.
02/11/2008	SUPPL-6	Labeling		Label is not available on this site.
10/25/2007	SUPPL-5	Labeling		Label is not available on this site.
03/26/2007	SUPPL-4	Labeling		Label is not available on this site.
03/16/1995	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 089990

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	211610	HIBROW HLTHCARE
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

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