Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206245
Company: NOVEL LABS INC
Company: NOVEL LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET;ORAL | Discontinued | None | No | No |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Discontinued | None | No | No |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
12/01/2016 | 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 |
---|---|---|---|---|---|
03/18/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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03/18/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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10/11/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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09/20/2018 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-5 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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12/18/2017 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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12/18/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |