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Details for New Drug Application (NDA): 020021

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NDA 020021 describes SUDAFED 24 HOUR, which is a drug marketed by J And J Consumer Inc and is included in one NDA. It is available from one supplier. Additional details are available on the SUDAFED 24 HOUR profile page.

The generic ingredient in SUDAFED 24 HOUR is pseudoephedrine hydrochloride. There are forty-nine drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.

Summary for NDA: 020021

Tradename:
SUDAFED 24 HOUR
Applicant:
J And J Consumer Inc
Ingredient:
pseudoephedrine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020021

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUDAFED 24 HOUR
pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 020021 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-669 50580-669-10 2 BLISTER PACK in 1 CARTON (50580-669-10) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Dec 15, 1992TE:RLD:Yes

Expired Orange Book Patents for NDA: 020021

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
SUDAFED 24 HOUR
pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020021-002Dec 15, 19924,576,604► subscribe
J And J Consumer Inc
SUDAFED 24 HOUR
pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020021-002Dec 15, 19924,801,461► subscribe
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