Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040400
Company: SPECGX LLC
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 07/26/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40400ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2024 | SUPPL-41 | REMS-Modified |
Label is not available on this site. |
||
| 02/11/2025 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/11/2019 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-27 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 03/20/2017 | SUPPL-25 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2011 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/15/2010 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/27/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/14/2004 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/21/2003 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/22/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/16/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
TABLET;ORAL; 325MG;10MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 209037 | ABHAI LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 040746 | AMNEAL PHARMS NY |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 211487 | ASCENT PHARMS INC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 201013 | AUROLIFE PHARMA LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 209924 | ELITE LABS INC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 203863 | EPIC PHARMA LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 211729 | GRANULES |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 202991 | RHODES PHARMS |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 040400 | SPECGX LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 202935 | STRIDES PHARMA INTL |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 202214 | TRIS PHARMA INC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 210211 | WES PHARMA INC |