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FDA Approval

Opium Tincture Deodorized

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

FDA Approval Summary

Company
Effective Date
December 5, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Morphine(1 g in 100 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

ANI Pharmaceuticals, Inc.

145588013

Products1

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

Opium Tincture Deodorized

Product Details

NDC Product Code
62559-153
Route of Administration
ORAL
Effective Date
June 20, 2017
WATERInactive
Code: 059QF0KO0RClass: IACT
MorphineActive
Code: 76I7G6D29CClass: ACTIBQuantity: 1 g in 100 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
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