Details for New Drug Application (NDA): 019941
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The generic ingredient in EMLA is lidocaine; prilocaine. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.
Summary for 019941
Tradename: | EMLA |
Applicant: | Teva Branded Pharm |
Ingredient: | lidocaine; prilocaine |
Patents: | 0 |
Suppliers and Packaging for NDA: 019941
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EMLA | lidocaine; prilocaine | CREAM;TOPICAL | 019941 | NDA AUTHORIZED GENERIC | Proficient Rx LP | 63187-577 | 63187-577-30 | 1 TUBE in 1 CARTON (63187-577-30) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 30, 1992 | TE: | RLD: | Yes |
Expired US Patents for NDA 019941
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Branded Pharm | EMLA | lidocaine; prilocaine | CREAM;TOPICAL | 019941-001 | Dec 30, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | EMLA | lidocaine; prilocaine | CREAM;TOPICAL | 019941-001 | Dec 30, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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