Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040838
Company: PHARM ASSOC
Company: PHARM ASSOC
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 |
---|---|---|---|---|---|---|---|
05/10/2013 | 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 |
---|---|---|---|---|---|
10/11/2019 | SUPPL-15 | 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-11 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
12/16/2016 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
12/15/2016 | SUPPL-2 | 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 | ANDA REPOSITORY |
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 | 200343 | VISTAPHARM |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG/15ML;7.5MG/15ML | SOLUTION;ORAL | Prescription | No | AA | 211023 | WES PHARMA INC |
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