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Details for New Drug Application (NDA): 087953

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NDA 087953 describes PROMETHAZINE PLAIN, which is a drug marketed by Wockhardt and is included in one NDA. It is available from six suppliers. Additional details are available on the PROMETHAZINE PLAIN profile page.

The generic ingredient in PROMETHAZINE PLAIN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.

Summary for NDA: 087953

promethazine hydrochloride
Therapeutic Class:Antiemetics
Respiratory Tract Agents

Pharmacology for NDA: 087953


Suppliers and Packaging for NDA: 087953

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
promethazine hydrochloride
SYRUP;ORAL 087953 ANDA Atlantic Biologicals Corps 17856-0608 17856-0608-5 5 mL in 1 CUP (17856-0608-5)
promethazine hydrochloride
SYRUP;ORAL 087953 ANDA Rebel Distributors Corp 21695-703 21695-703-04 118 mL in 1 BOTTLE (21695-703-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength6.25MG/5ML
Approval Date:Nov 15, 1982TE:AARLD:Yes

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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 verifification 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.