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
ABACAVIR SULFATE AND LAMIVUDINE از شرکت LUPIN LTD
Abbreviated New Drug Application (ANDA): 204990
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 03/28/2017 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204990Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/24/2020 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/24/2020 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/24/2020 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
ABACAVIR SULFATE AND LAMIVUDINE
TABLET;ORAL; EQ 600MG BASE;300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | No | AB | 090159 | AUROBINDO PHARMA LTD |
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | No | AB | 206151 | AUROBINDO PHARMA LTD |
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | No | AB | 091144 | CIPLA |
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | No | AB | 204990 | LUPIN LTD |
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | No | AB | 079246 | TEVA PHARMS USA |
| EPZICOM | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | Yes | AB | 021652 | VIIV HLTHCARE |
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