Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040419
Company: SPECGX LLC
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | AA | No | Yes |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | AA | No | Yes |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/31/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40419ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2024 | SUPPL-38 | REMS-Modified |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-24 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 04/06/2018 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/06/2018 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/30/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/13/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/13/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/13/2002 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/11/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
ACETAMINOPHEN AND CODEINE PHOSPHATE
TABLET;ORAL; 300MG;15MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 202800 | AUROLIFE PHARMA LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 212418 | ELITE LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 040419 | SPECGX LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 089990 | STRIDES PHARMA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 211610 | WES PHARMA INC |
TABLET;ORAL; 300MG;30MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 040779 | AMNEAL PHARMS NY |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 202800 | AUROLIFE PHARMA LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 212418 | ELITE LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 040419 | SPECGX LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 089805 | STRIDES PHARMA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 211610 | WES PHARMA INC |
TABLET;ORAL; 300MG;60MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 202800 | AUROLIFE PHARMA LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 212418 | ELITE LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 040419 | SPECGX LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 089828 | STRIDES PHARMA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 087083 | SUN PHARM INDS LTD |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 211610 | WES PHARMA INC |