Details for New Drug Application (NDA): 021903
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The generic ingredient in NEOPROFEN is ibuprofen lysine. There are sixty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen lysine profile page.
Summary for 021903
Tradename: | NEOPROFEN |
Applicant: | Recordati Rare |
Ingredient: | ibuprofen lysine |
Patents: | 1 |
Pharmacology for NDA: 021903
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 021903
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903 | NDA | Recordati Rare Diseases Inc. | 55292-122 | 55292-122-52 | 3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL |
NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-490 | 66993-490-36 | 3 VIAL in 1 CARTON (66993-490-36) / 2 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) | ||||
Approval Date: | Apr 13, 2006 | TE: | AP | RLD: | Yes | ||||
Patent: | 8,415,337 | Patent Expiration: | Mar 2, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 021903
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903-001 | Apr 13, 2006 | 6,342,530 | ⤷ Subscribe |
Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903-001 | Apr 13, 2006 | 6,344,479 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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