Details for New Drug Application (NDA): 021234
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The generic ingredient in FLECTOR is diclofenac epolamine. There are forty-seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the diclofenac epolamine profile page.
Summary for 021234
Tradename: | FLECTOR |
Applicant: | Ibsa |
Ingredient: | diclofenac epolamine |
Patents: | 0 |
Pharmacology for NDA: 021234
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 021234
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLECTOR | diclofenac epolamine | SYSTEM;TOPICAL | 021234 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA Inc. | 0093-3727 | 0093-3727-55 | 6 POUCH in 1 CARTON (0093-3727-55) / 5 SYSTEM in 1 POUCH (0093-3727-50) |
FLECTOR | diclofenac epolamine | SYSTEM;TOPICAL | 021234 | NDA AUTHORIZED GENERIC | Quality Care Products, LLC | 55700-886 | 55700-886-30 | 6 POUCH in 1 CARTON (55700-886-30) / 5 SYSTEM in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TOPICAL | Strength | 1.3% | ||||
Approval Date: | Jan 31, 2007 | TE: | RLD: | Yes |
Expired US Patents for NDA 021234
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ibsa | FLECTOR | diclofenac epolamine | SYSTEM;TOPICAL | 021234-001 | Jan 31, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Ibsa | FLECTOR | diclofenac epolamine | SYSTEM;TOPICAL | 021234-001 | Jan 31, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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