Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208269
Company: ALVOGEN

• REMS

Products on ANDA 208269

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208269

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/01/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208269Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2024	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 208269

HYDROCODONE BITARTRATE

TABLET, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN