Details for New Drug Application (NDA): 017941
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NDA 017941 describes SUDAFED 12 HOUR, which is a drug marketed by Glaxosmithkline and Mcneil Cons and is included in two NDAs. Additional details are available on the SUDAFED 12 HOUR profile page.
The generic ingredient in SUDAFED 12 HOUR is pseudoephedrine hydrochloride. There are forty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.
The generic ingredient in SUDAFED 12 HOUR is pseudoephedrine hydrochloride. There are forty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.
Summary for 017941
| Tradename: | SUDAFED 12 HOUR |
| Applicant: | Glaxosmithkline |
| Ingredient: | pseudoephedrine hydrochloride |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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