Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201107
Company: HETERO LABS LTD III
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 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201107Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201107s000TAltr.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 |