Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204209
Company: LARKEN LABS INC
Company: LARKEN LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE | ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | 325MG;30MG;16MG | 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 |
---|---|---|---|---|---|---|---|
09/30/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204209Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-12 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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10/07/2019 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/20/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-7 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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11/09/2018 | SUPPL-6 | Labeling-Proprietary Name Change, Labeling-Container/Carton Labels |
Label is not available on this site. |
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08/29/2017 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |