Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205814
Company: AUROLIFE PHARMA LLC
Company: AUROLIFE PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | AB | No | No |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | AB | No | No |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET;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 |
---|---|---|---|---|---|---|---|
05/13/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/07/2020 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/07/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/18/2018 | SUPPL-2 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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04/07/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
HYDROMORPHONE HYDROCHLORIDE
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | Yes | AB | 019892 | RHODES PHARMS |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 210506 | ASCENT PHARMS INC |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 205814 | AUROLIFE PHARMA LLC |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 078439 | LANNETT |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 076855 | SPECGX LLC |
TABLET;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | Yes | AB | 019892 | RHODES PHARMS |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AB | 210506 | ASCENT PHARMS INC |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AB | 205814 | AUROLIFE PHARMA LLC |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AB | 078439 | LANNETT |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AB | 076855 | SPECGX LLC |
TABLET;ORAL; 8MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET;ORAL | Prescription | Yes | AB | 019892 | RHODES PHARMS |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET;ORAL | Prescription | No | AB | 210506 | ASCENT PHARMS INC |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET;ORAL | Prescription | No | AB | 205814 | AUROLIFE PHARMA LLC |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET;ORAL | Prescription | No | AB | 076855 | SPECGX LLC |