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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205629
Company: OSMOTICA PHARM US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 12MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 16MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 32MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/07/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205629Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/12/2024 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/04/2021 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/03/2021 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
03/03/2021 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/18/2018 SUPPL-6 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/26/2017 SUPPL-3 REMS-Modified

Label is not available on this site.
09/30/2016 SUPPL-1 REMS - MODIFIED - D-N-A

Label is not available on this site.

HYDROMORPHONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212133 ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205629 OSMOTICA PHARM US
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204278 PADAGIS US

TABLET, EXTENDED RELEASE;ORAL; 12MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 12MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212133 ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 12MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205629 OSMOTICA PHARM US
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 12MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204278 PADAGIS US

TABLET, EXTENDED RELEASE;ORAL; 16MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 16MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212133 ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 16MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205629 OSMOTICA PHARM US
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 16MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204278 PADAGIS US

TABLET, EXTENDED RELEASE;ORAL; 32MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 32MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212133 ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 32MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205629 OSMOTICA PHARM US
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 32MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204278 PADAGIS US
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