MedPath
FDA Approval

COMPLERA

March 15, 2013

HUMAN PRESCRIPTION DRUG LABEL

Emtricitabine(200 mg in 1 1)
Rilpivirine(25 mg in 1 1)
Tenofovir disoproxil(300 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (1)

COMPLERA

54868-6360

NDA202123

NDA (C73594)

ORAL

March 15, 2013

Code: G70B4ETF4SClass: ACTIBQuantity: 200 mg in 1 1
Code: 212WAX8KDDClass: ACTIMQuantity: 25 mg in 1 1
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
Code: OTT9J7900IClass: ACTIBQuantity: 300 mg in 1 1
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
PovidonesInactive
Code: FZ989GH94EClass: IACT
polysorbate 20Inactive
Code: 7T1F30V5YHClass: IACT
aluminum oxideInactive
Code: LMI26O6933Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
starch, cornInactive
Code: O8232NY3SJClass: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQKClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1AClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
ferric oxide redInactive
Code: 1K09F3G675Class: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8Class: IACT
triacetinInactive
Code: XHX3C3X673Class: IACT
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