Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205651
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEVIRAPINE | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
10/27/2014 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/21/2019 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/21/2019 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/21/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
NEVIRAPINE
TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NEVIRAPINE | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206879 | MACLEODS PHARMS LTD |
NEVIRAPINE | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205651 | MYLAN |
NEVIRAPINE | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203411 | SANDOZ |
VIRAMUNE XR | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 201152 | BOEHRINGER INGELHEIM |