Details for New Drug Application (NDA): 022315
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The generic ingredient in OZURDEX is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
Summary for 022315
Tradename: | OZURDEX |
Applicant: | Abbvie |
Ingredient: | dexamethasone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022315
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 022315
Suppliers and Packaging for NDA: 022315
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315 | NDA | Allergan, Inc. | 0023-3348 | 0023-3348-07 | 1 POUCH in 1 CARTON (0023-3348-07) / 1 IMPLANT in 1 POUCH |
OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315 | NDA | Allergan, Inc. | 0023-3348 | 0023-3348-08 | 1 POUCH in 1 CARTON (0023-3348-08) / 1 IMPLANT in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | IMPLANT;INTRAVITREAL | Strength | 0.7MG | ||||
Approval Date: | Jun 17, 2009 | TE: | RLD: | Yes |
Expired US Patents for NDA 022315
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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