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FDA Approval

Griseofulvin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Sandoz Inc
DUNS: 005387188
Effective Date
December 20, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Griseofulvin(500 mg in 1 1)

Products2

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

Griseofulvin

Product Details

NDC Product Code
0781-5515
Application Number
ANDA091592
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 20, 2016
Code: 32HRV3E3D5Class: ACTIBQuantity: 500 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

Griseofulvin

Product Details

NDC Product Code
0781-5514
Application Number
ANDA091592
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 20, 2016
Code: 32HRV3E3D5Class: ACTIBQuantity: 250 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
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