Regulations.gov document
Enclosure 2 Labeling of the Reference Listed Drug Product - Omnicef (cefdinir) for Oral…
Supporting & Related Material · FDA-2006-P-0013 · posted Mar 30, 2009
Key facts
| Document ID | FDA-2006-P-0013-0006 |
|---|---|
| Title | Enclosure 2 Labeling of the Reference Listed Drug Product - Omnicef (cefdinir) for Oral Suspension, 250 mg/5 mL [NDA #50-749, Holder - Abbott Laboratories] re: Enclosure 1 Labeling of the Proposed Product - Cefdinir Chewable Tablets 187.5 mg, 250 mg, and 300 mg re: Citizen Petition from Lupin Pharmaceuticals, Inc. |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2006-P-0013 |
| Posted | Mar 30, 2009 |
| Effective date | Jun 22, 2006 |
At a glance
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