Drugs@FDA: FDA-Approved Drugs
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 12/07/1983 | 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 |
|---|---|---|---|---|---|
| 03/04/2024 | SUPPL-56 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-55 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-54 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-49 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/11/2019 | SUPPL-45 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-42 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-38 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2011 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/23/2007 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 10/25/2004 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 01/09/2003 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/17/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/16/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/20/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
OXYCET
TABLET;ORAL; 325MG;5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 087463 | SPECGX LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 210644 | ABHAI LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 201447 | ACTAVIS ELIZABETH |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 202677 | ALVOGEN |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 040777 | AMNEAL PHARMS |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 207419 | ASCENT PHARMS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 201972 | AUROLIFE PHARMA LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 207834 | CHARTWELL |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 203864 | EPIC PHARMA LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 204407 | NOVEL LABS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 201278 | RHODES PHARMS |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 207510 | WES PHARMA INC |
| PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 040330 | ENDO OPERATIONS |