Details for New Drug Application (NDA): 074612
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NDA 074612 describes NICOTINE, which is a drug marketed by Difgen Pharms, Fertin Pharma, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Aurobindo Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pld Acquisitions, and Ppi-dac, and is included in fifty NDAs. It is available from fifteen suppliers. Additional details are available on the NICOTINE profile page.
The generic ingredient in NICOTINE is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
The generic ingredient in NICOTINE is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty-one 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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