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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211610
Company: HIBROW HLTHCARE

Products on ANDA 211610

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
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Prescription	AA	No	No
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 211610

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2019	ORIG-1	Approval		STANDARD		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-6	REMS - MODIFIED - D-N-A		Label is not available on this site.
03/05/2025	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/30/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211610

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

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	211610	HIBROW HLTHCARE
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

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	211610	HIBROW HLTHCARE
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

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