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FDA Approval

Misoprostol

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

FDA Approval Summary

Company
Effective Date
January 15, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Misoprostol(200 ug in 1 1)

Products2

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

Misoprostol

Product Details

NDC Product Code
33261-076
Application Number
ANDA091667
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 15, 2014
Code: 0E43V0BB57Class: ACTIBQuantity: 200 ug in 1 1
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT

Misoprostol

Product Details

NDC Product Code
33261-754
Application Number
ANDA091667
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 15, 2014
Code: 0E43V0BB57Class: ACTIBQuantity: 100 ug in 1 1
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
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