Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040658
Company: CHARTWELL
Company: CHARTWELL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET;ORAL | Prescription | AA | No | Yes |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET;ORAL | Prescription | AA | No | Yes |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;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 |
|---|---|---|---|---|---|---|---|
| 01/19/2006 | 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 |
|---|---|---|---|---|---|
| 03/18/2024 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/11/2019 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-12 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 08/24/2018 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/15/2016 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf | |
| 06/27/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/10/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/18/2013 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
TABLET;ORAL; 300MG;5MG
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 | 300MG;5MG | TABLET;ORAL | Prescription | No | AA | 209036 | ABHAI LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET;ORAL | Prescription | No | AA | 206869 | AMNEAL PHARMS NY |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET;ORAL | Prescription | No | AA | 207709 | AUROLIFE PHARMA LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET;ORAL | Prescription | No | AA | 040658 | CHARTWELL |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET;ORAL | Prescription | No | AA | 207808 | RHODES PHARMS |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET;ORAL | Prescription | No | AA | 206718 | SPECGX LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET;ORAL | Prescription | No | AA | 202214 | TRIS PHARMA INC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET;ORAL | Prescription | No | AA | 207509 | WES PHARMA INC |
TABLET;ORAL; 300MG;7.5MG
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 | 300MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 209036 | ABHAI LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 207709 | AUROLIFE PHARMA LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 040658 | CHARTWELL |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 207808 | RHODES PHARMS |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 206718 | SPECGX LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 202214 | TRIS PHARMA INC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 207509 | WES PHARMA INC |
TABLET;ORAL; 300MG;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 | 300MG;10MG | TABLET;ORAL | Prescription | No | AA | 209036 | ABHAI LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET;ORAL | Prescription | No | AA | 207137 | AMNEAL PHARMS |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET;ORAL | Prescription | No | AA | 207709 | AUROLIFE PHARMA LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET;ORAL | Prescription | No | AA | 040658 | CHARTWELL |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET;ORAL | Prescription | No | AA | 207808 | RHODES PHARMS |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET;ORAL | Prescription | No | AA | 206718 | SPECGX LLC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET;ORAL | Prescription | No | AA | 202214 | TRIS PHARMA INC |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET;ORAL | Prescription | No | AA | 207509 | WES PHARMA INC |