Details for New Drug Application (NDA): 208845
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NDA 208845 describes ZILRETTA, which is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ZILRETTA profile page.
The generic ingredient in ZILRETTA is triamcinolone acetonide. There is one drug master file entry for this compound. Eighty suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
The generic ingredient in ZILRETTA is triamcinolone acetonide. There is one drug master file entry for this compound. Eighty suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
Summary for 208845
| Tradename: | ZILRETTA |
| Applicant: | Pacira Pharms Inc |
| Ingredient: | triamcinolone acetonide |
| Patents: | 2 |
Medical Subject Heading (MeSH) Categories for 208845
Suppliers and Packaging for NDA: 208845
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZILRETTA | triamcinolone acetonide | FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR | 208845 | NDA | Pacira Pharmaceuticals, Inc. | 65250-003 | 65250-003-01 | 1 KIT in 1 CARTON (65250-003-01) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (65250-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (65250-002-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR | Strength | 32MG/VIAL | ||||
| Approval Date: | Oct 6, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 4, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 4, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING PAIN OR INFLAMMATION WITH AN INJECTABLE CONTROLLED OR SUSTAINED RELEASE FORMULATION OF TRIAMCINOLONE ACETONIDE | ||||||||
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