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Trimipramine Maleate

TRIMIPRAMINE MALEATE CAPSULES, 25 MG, 50 MG and 100 MG Rx Only

Approved
Approval ID

479c7dc5-61e1-4bf2-b0bd-5d80865192af

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 14, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Trimipramine Maleate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72162-2063
Application NumberANDA077361
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trimipramine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification

INGREDIENTS (11)

TRIMIPRAMINE MALEATEActive
Quantity: 100 mg in 1 1
Code: 269K6498LD
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT

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Trimipramine Maleate - FDA Drug Approval Details