Drugs@FDA: FDA-Approved Drugs
Company: STRIDES PHARMA
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/31/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40355ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-43 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
03/04/2021 | SUPPL-42 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
10/11/2019 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
10/11/2019 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/21/2018 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2018 | SUPPL-35 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
12/16/2016 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2016 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
12/15/2016 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2016 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
12/15/2016 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
12/15/2016 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
10/22/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
07/01/2011 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
07/08/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
11/18/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
06/06/2002 | SUPPL-1 | Manufacturing (CMC) |
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 |