MedPath
FDA Approval

Tolvaptan

September 5, 2022

HUMAN PRESCRIPTION DRUG LABEL

Tolvaptan(30 mg in 1 1)

Manufacturing Establishments (1)

Annora Pharma Private Limited

Camber Pharmaceuticals, Inc.

650980746

Products (2)

Tolvaptan

31722-869

ANDA205646

ANDA (C73584)

ORAL

September 5, 2022

STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TolvaptanActive
Code: 21G72T1950Class: ACTIBQuantity: 30 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15Class: IACT

Tolvaptan

31722-868

ANDA205646

ANDA (C73584)

ORAL

September 5, 2022

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
TolvaptanActive
Code: 21G72T1950Class: ACTIBQuantity: 15 mg in 1 1
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15Class: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0AClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
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