Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206986
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 50MG CAPSULE, 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
01/21/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206986Orig1s000ltr.pdf

HYDROCODONE BITARTRATE

CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206986 ALVOGEN
ZOHYDRO ER HYDROCODONE BITARTRATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 202880 PERSION

CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206986 ALVOGEN
ZOHYDRO ER HYDROCODONE BITARTRATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 202880 PERSION

CAPSULE, 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 CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206986 ALVOGEN
ZOHYDRO ER HYDROCODONE BITARTRATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 202880 PERSION

CAPSULE, 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 CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206986 ALVOGEN
ZOHYDRO ER HYDROCODONE BITARTRATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 202880 PERSION

CAPSULE, 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 CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206986 ALVOGEN
ZOHYDRO ER HYDROCODONE BITARTRATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 202880 PERSION

CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206986 ALVOGEN
ZOHYDRO ER HYDROCODONE BITARTRATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 202880 PERSION

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