Drugs@FDA: FDA-Approved Drugs
Company: GENUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG/15ML;7.5MG/15ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
07/19/2011 | 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 |
---|---|---|---|---|---|
03/11/2024 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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04/20/2022 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/07/2019 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/21/2018 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-10 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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12/16/2016 | SUPPL-9 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/16/2016 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
01/05/2016 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
10/18/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
SOLUTION;ORAL; 325MG/15ML;7.5MG/15ML
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/15ML;7.5MG/15ML | SOLUTION;ORAL | Prescription | No | AA | 040482 | CHARTWELL |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG/15ML;7.5MG/15ML | SOLUTION;ORAL | Prescription | No | AA | 040894 | GENUS |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG/15ML;7.5MG/15ML | SOLUTION;ORAL | Prescription | No | AA | 040838 | PHARM ASSOC |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG/15ML;7.5MG/15ML | SOLUTION;ORAL | Prescription | No | AA | 211023 | WES PHARMA INC |