Details for New Drug Application (NDA): 020385
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NDA 020385 describes NICOTROL, which is a drug marketed by Mcneil Cons, Pfizer, and Pfizer Inc, and is included in three NDAs. It is available from one supplier. Additional details are available on the NICOTROL profile page.
The generic ingredient in NICOTROL is nicotine. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicotine profile page.
The generic ingredient in NICOTROL is nicotine. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicotine profile page.
Summary for 020385
| Tradename: | NICOTROL |
| Applicant: | Pfizer Inc |
| Ingredient: | nicotine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020385
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICOTROL | nicotine | SPRAY, METERED;NASAL | 020385 | NDA | Pharmacia & Upjohn Company LLC | 0009-5401 | 0009-5401-01 | 4 BOTTLE, SPRAY in 1 BOX (0009-5401-01) / 10 mL in 1 BOTTLE, SPRAY |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.5MG/SPRAY | ||||
| Approval Date: | Mar 22, 1996 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020385
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer Inc | NICOTROL | nicotine | SPRAY, METERED;NASAL | 020385-001 | Mar 22, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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