Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090159
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA 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 |
---|---|---|---|---|---|---|---|
11/15/2018 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/18/2023 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/18/2023 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/07/2020 | SUPPL-2 | 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 | 204990 | CHARTWELL RX |
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 | 216332 | LAURUS |