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Details for New Drug Application (NDA): 075153

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NDA 075153 describes PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds Ltd, Perrigo, Cent Pharms, Graham Dm, Kv Pharm, and Sandoz, and is included in seven NDAs. It is available from thirty-two suppliers. Additional details are available on the PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in PSEUDOEPHEDRINE HYDROCHLORIDE is pseudoephedrine hydrochloride; triprolidine hydrochloride. There are forty-nine drug master file entries for this compound. Additional details are available on the pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.

Summary for NDA: 075153

Tradename:
PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant:
Perrigo
Ingredient:
pseudoephedrine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 075153

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 075153 ANDA L Perrigo Company 0113-0054 0113-0054-52 1 BLISTER PACK in 1 CARTON (0113-0054-52) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 075153 ANDA L Perrigo Company 0113-2054 0113-2054-60 2 BLISTER PACK in 1 CARTON (0113-2054-60) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Feb 26, 1999TE:RLD:No


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