DOXYCYCLINE | N050641 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Petition for Stay of Action from CollaGenex Pharmaceuticals, Inc. FDA-2002-P-0290 · 12 docket documents CollaGenex Pharmaceuticals, Inc. filed this July 2002 petition under 21 C.F.R. § 10.35 requesting a stay of action on any abbreviated new drug application (ANDA) for a generic version of Periostat (doxycycline hyclate) 20 mg capsules, which CollaGenex had voluntarily withdrawn from sale in 2001, pen | 505(q) Stay Request | 2018-03-29 | Granted | — |
Citizen Petitions from Mayne Pharma lnternational Pty Ltd FDA-2016-P-4047 · 4 docket documents Mayne Pharma International Pty Ltd filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require specific in vitro dissolution criteria for any ANDA referencing Doryx MPC (doxycycline hyclate delayed-release tablets), the company's refer | 505(q) | 2016-11-28 | Open | — |
Warner Chilcott, LLC and Mayne Pharmaceuticals International Pty Ltd. - Citiz... FDA-2011-P-0702 · 3 docket documents Warner Chilcott, LLC and Mayne Pharmaceuticals International Pty Ltd., the U.S. agent and sponsor respectively of Doryx (doxycycline hyclate delayed-release tablets) NDA 50-795, filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refra | 505(q) | 2011-09-27 | Denied | — |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0341 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Doxycycline Monohydrate Tablets, 125 mg, suitable for submission in an abbreviated new drug application, using Adoxa Tabl | Other | 2009-01-08 | Open | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.2349
per ea
Lowest NADAC/Unit
$0.1559
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 62135026225DOXYCYCLINE MONO 100 MG CAP | $0.2349 | EA | Generic | — | 2026-06-17 |
| 62135026250DOXYCYCLINE MONO 100 MG CAP | $0.2349 | EA | Generic | — | 2026-06-17 |
| 62135026260DOXYCYCLINE MONO 100 MG CAP | $0.2349 | EA | Generic | — | 2026-06-17 |
| 62135026001DOXYCYCLINE MONO 50 MG CAP | $0.1559 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.