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 از شرکت HETERO LABS LTD III
Abbreviated New Drug Application (ANDA): 201107
Company: HETERO LABS LTD III
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 20MG BASE/ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 09/26/2016 | ORIG-1 | Approval |
Not Applicable |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201107Orig1s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/26/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201107Orig1s000lbl.pdf |
ABACAVIR SULFATE
SOLUTION;ORAL; EQ 20MG BASE/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 20MG BASE/ML | SOLUTION;ORAL | Prescription | No | AA | 077950 | AUROBINDO PHARMA LTD |
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 20MG BASE/ML | SOLUTION;ORAL | Prescription | No | AA | 201107 | HETERO LABS LTD III |
| ZIAGEN | ABACAVIR SULFATE | EQ 20MG BASE/ML | SOLUTION;ORAL | Prescription | Yes | AA | 020978 | VIIV HLTHCARE |
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