Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207709
Company: AUROLIFE PHARMA LLC
Company: AUROLIFE PHARMA LLC
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 | No |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET;ORAL | Prescription | AA | No | No |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;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 |
---|---|---|---|---|---|---|---|
09/13/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/06/2024 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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03/18/2024 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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03/18/2024 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/18/2024 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/04/2021 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/11/2019 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-1 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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 | 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 | 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 |