Details for New Drug Application (NDA): 074612
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The generic ingredient in NICOTINE is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 074612
Tradename: | NICOTINE |
Applicant: | Difgen Pharms |
Ingredient: | nicotine |
Patents: | 0 |
Suppliers and Packaging for NDA: 074612
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NICOTINE | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 074612 | ANDA | Walgreens | 0363-1243 | 0363-1243-01 | 14 POUCH in 1 CARTON (0363-1243-01) / 1 h in 1 POUCH |
NICOTINE | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 074612 | ANDA | Walgreens | 0363-1244 | 0363-1244-01 | 14 POUCH in 1 CARTON (0363-1244-01) / 1 h in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 21MG/24HR | ||||
Approval Date: | Oct 20, 1997 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 7MG/24HR | ||||
Approval Date: | Jul 28, 2003 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 14MG/24HR | ||||
Approval Date: | Oct 20, 1997 | TE: | RLD: | No |
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