Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076855
Company: SPECGX LLC
Company: SPECGX LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET;ORAL | Prescription | AB | No | No |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | AB | No | No |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 4MG | 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 |
---|---|---|---|---|---|---|---|
12/23/2004 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/09/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
03/09/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2018 | SUPPL-13 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
03/09/2020 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/06/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
11/09/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
HYDROMORPHONE HYDROCHLORIDE
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 |
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 |