اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE از شرکت LARKEN LABS INC
Abbreviated New Drug Application (ANDA): 204209
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 | Prescription |
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 |
|
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 |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-7 | REMS – PROPOSAL – D-N-A |
Label is not available on this site. |
||
| 11/09/2018 | SUPPL-6 | Labeling-Proprietary Name Change, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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