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FDA Approval

Diphenoxylate Hydrochloride and Atropine Sulfate

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

FDA Approval Summary

Company
Physicians Total Care, Inc.
DUNS: 194123980
Effective Date
January 25, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atropine(0.025 mg in 1 1)
Diphenoxylate(2.5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products1

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

Diphenoxylate Hydrochloride and Atropine Sulfate

Product Details

NDC Product Code
54868-0032
Application Number
ANDA085762
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 25, 2011
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
AtropineActive
Code: 03J5ZE7KA5Class: ACTIBQuantity: 0.025 mg in 1 1
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
DiphenoxylateActive
Code: W24OD7YW48Class: ACTIBQuantity: 2.5 mg in 1 1
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