You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 083312


✉ Email this page to a colleague

« Back to Dashboard


NDA 083312 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Taro, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, and Ani Pharms, and is included in ninety NDAs. It is available from forty-seven suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 083312
Tradename:PROMETHAZINE HYDROCHLORIDE
Applicant:Hikma
Ingredient:promethazine hydrochloride
Patents:0
Pharmacology for NDA: 083312
Medical Subject Heading (MeSH) Categories for 083312
Suppliers and Packaging for NDA: 083312
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 083312 ANDA Henry Schein, Inc. 0404-9940 0404-9940-01 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9940-01) / 1 mL in 1 VIAL, SINGLE-DOSE
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 083312 ANDA Henry Schein, Inc. 0404-9941 0404-9941-01 1 AMPULE in 1 BAG (0404-9941-01) / 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.