Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204278
Company: PADDOCK LLC
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 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
04/06/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204278Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-12 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-11 REMS-Modified

Label is not available on this site.

02/17/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/30/2016 SUPPL-6 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-3 REMS-Modified

Label is not available on this site.

10/20/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

06/26/2015 SUPPL-1 REMS-Proposal

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 205629 OSMOTICA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204278 PADDOCK LLC

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 205629 OSMOTICA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 12MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204278 PADDOCK LLC

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 205629 OSMOTICA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 16MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204278 PADDOCK LLC

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 205629 OSMOTICA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 32MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204278 PADDOCK LLC

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