Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203347
Company: HETERO LABS LTD III
Company: HETERO LABS LTD III
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MARAVIROC | MARAVIROC | 150MG | TABLET;ORAL | Prescription | AB | No | No |
MARAVIROC | MARAVIROC | 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 |
---|---|---|---|---|---|---|---|
02/07/2022 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203347Orig1s000ltr.pdf |
MARAVIROC
TABLET;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MARAVIROC | MARAVIROC | 150MG | TABLET;ORAL | Prescription | No | AB | 203347 | HETERO LABS LTD III |
MARAVIROC | MARAVIROC | 150MG | TABLET;ORAL | Prescription | No | AB | 217114 | I 3 PHARMS |
SELZENTRY | MARAVIROC | 150MG | TABLET;ORAL | Prescription | Yes | AB | 022128 | VIIV HLTHCARE |
TABLET;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MARAVIROC | MARAVIROC | 300MG | TABLET;ORAL | Prescription | No | AB | 203347 | HETERO LABS LTD III |
MARAVIROC | MARAVIROC | 300MG | TABLET;ORAL | Prescription | No | AB | 217114 | I 3 PHARMS |
SELZENTRY | MARAVIROC | 300MG | TABLET;ORAL | Prescription | Yes | AB | 022128 | VIIV HLTHCARE |