Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040746
Company: AMNEAL PHARMS NY
Company: AMNEAL PHARMS NY
| 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 | No |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/25/2006 | 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 |
|---|---|---|---|---|---|
| 02/06/2024 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2024 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2024 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2024 | SUPPL-31 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/10/2019 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-20 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/02/2015 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2014 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2016 | SUPPL-12 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 06/24/2011 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2013 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/20/2008 | 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 | 203863 | EPIC PHARMA LLC |
| 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 | 040355 | STRIDES PHARMA |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 202935 | STRIDES PHARMA |
| 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 |
TABLET;ORAL; 325MG;7.5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANEXSIA 7.5/325 | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 040405 | SPECGX LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 209037 | ABHAI LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 040746 | AMNEAL PHARMS NY |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 211487 | ASCENT PHARMS INC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 201013 | AUROLIFE PHARMA LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 040432 | CHARTWELL |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 203863 | EPIC PHARMA LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 202991 | RHODES PHARMS |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 040656 | STRIDES PHARMA |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 202935 | STRIDES PHARMA |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 202214 | TRIS PHARMA INC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 210211 | WES PHARMA INC |