MedPath

Tazorac

Approved
Approval ID

b2fbd294-5fb9-45bc-baf0-8c5b72bddb74

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 22, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

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

Tazarotene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-4456
Application NumberNDA020600
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tazarotene
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2010
FDA Product Classification

INGREDIENTS (11)

TAZAROTENEActive
Quantity: 1 mg in 1 g
Code: 81BDR9Y8PS
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CARBOMER HOMOPOLYMER TYPE BInactive
Code: HHT01ZNK31
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 40Inactive
Code: STI11B5A2X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT

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Tazorac - FDA Drug Approval Details