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Drugs@FDA: FDA-Approved Drugs

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

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

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

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
HYSINGLA ER HYDROCODONE BITARTRATE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 206627 PURDUE PHARMA LP
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