LAMIVUDINE; ZIDOVUDINE | A077558 | AUROBINDO PHARMA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lupin Limited - Reply Comment FDA-2010-P-0549 Lupin Limited filed this reply comment on behalf of itself regarding FDA docket FDA-2010-P-0549, responding to Teva Pharmaceuticals USA, Inc.'s comments about a citizen petition seeking 180-day generic exclusivity for lamivudine and zidovudine tablets 150mg/300mg under the Hatch-Waxman Act. Lupin co | 505(q) | 2011-01-14 | Denied | — |
Lupin Limited (Rakoczy Molino Mazzochi Siwik, LLP) - Citizen Petition FDA-2010-P-0549 Lupin Limited, represented by Rakoczy Molino Mazzochi Siwik LLP, filed this citizen petition on October 18, 2010, requesting that FDA confirm Teva Pharmaceuticals USA Inc. is not entitled to 180-day generic exclusivity under 21 U.S.C. § 355(j)(5)(B)(iv) for lamivudine and zidovudine tablets 150 mg/3 | 505(q) | 2010-10-26 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.7637
per ea
Lowest NADAC/Unit
$0.7637
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 65862003660LAMIVUDINE-ZIDOVUDINE TABLET | $0.7637 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.