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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
US Army
Argus Health

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087513

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NDA 087513 describes DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Alra, Anabolic, Barr, Elkins Sinn, Halsey, Heather, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lederle, LNK, Mk Labs, Mutual Pharm, Newtron Pharms, Nexgen Pharma Inc, Perrigo, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sandoz, Sun Pharm Industries, Superpharm, Teva, Valeant Pharm Intl, Vangard, Watson Labs, Whiteworth Town Plsn, Bundy, Cenci, Kv Pharm, Naska, Pharm Assoc, App Pharms, Bel Mar, Eurohlth Intl Sarl, Hospira, Lyphomed, Mylan Institutional, Watson Labs Teva, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Hi Tech Pharma, Abraxis Pharm, Fresenius Kabi Usa, and Intl Medication, and is included in seventy-three NDAs. It is available from eighteen suppliers. Additional details are available on the DIPHENHYDRAMINE HYDROCHLORIDE profile page.

The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
Summary for 087513
Applicant:Pharm Assoc
Ingredient:diphenhydramine hydrochloride
Therapeutic Class:Antiemetics
Antiparkinson Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 087513
Suppliers and Packaging for NDA: 087513
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride ELIXIR;ORAL 087513 ANDA Pharmaceutical Associates, Inc. 0121-0489 0121-0489-00 10 TRAY in 1 CASE (0121-0489-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0489-05)
DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride ELIXIR;ORAL 087513 ANDA Pharmaceutical Associates, Inc. 0121-0489 0121-0489-10 10 TRAY in 1 CASE (0121-0489-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:ELIXIR;ORALStrength12.5MG/5ML
Approval Date:Feb 10, 1982TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health

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