U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 018337

Expand all

ACETAMINOPHEN (ACETAMINOPHEN)
120MG
Marketing Status: Over-the-counter
Active Ingredient: ACETAMINOPHEN
Proprietary Name: ACETAMINOPHEN
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018337
Product Number: 003
Approval Date: Sep 12, 1983
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
ACETAMINOPHEN (ACETAMINOPHEN)
325MG
Marketing Status: Over-the-counter
Active Ingredient: ACETAMINOPHEN
Proprietary Name: ACETAMINOPHEN
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 325MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018337
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
ACETAMINOPHEN (ACETAMINOPHEN)
650MG
Marketing Status: Over-the-counter
Active Ingredient: ACETAMINOPHEN
Proprietary Name: ACETAMINOPHEN
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 650MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018337
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
INFANTS' FEVERALL (ACETAMINOPHEN)
80MG
Marketing Status: Over-the-counter
Active Ingredient: ACETAMINOPHEN
Proprietary Name: INFANTS' FEVERALL
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018337
Product Number: 004
Approval Date: Aug 26, 1992
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
Back to Top