Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216332
Company: LAURUS
Company: LAURUS
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 |
---|---|---|---|---|---|---|---|
07/25/2022 | ORIG-1 | Approval | STANDARD |
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 |