HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | N005213 | GENUS LIFESCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Vintage Pharmaceutical, Inc. - Citizen Petition FDA-2008-P-0555 · 5 docket documents Vintage Pharmaceutical, Inc. filed this citizen petition on October 15, 2008, requesting that the FDA determine that Endo Pharmaceuticals' Hycodan® (Hydrocodone Bitartrate and Homatropine Methylbromide) Tablets, which is designated as a Reference Listed Drug under NDA 05-213, was voluntarily discont | 505(q) | 2008-10-22 | Granted | — |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0004 · 8 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Hydrocodone Bitartrate and Homatropine Methylbromide Syrup at a lower strength of 2.5 mg/0.75 mg per 5 mL suitable for submission as an abbreviated new drug application, with the reference lis | Other | 2008-05-13 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0124 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Hydrocodone Bitartrate and Homatropine Methylbromide Tablets at 2.5 mg/0.75 mg suitable for submission as an ANDA, with the reference listed drug being Hycodan at 5 mg/1.5 mg (NDA 05-2 | Other | 2008-04-18 | Granted | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.9623
per ea
Lowest NADAC/Unit
$0.1005
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 64950020603HYDROCODONE-HOMATROPINE 5-1.5 MG TABLET | $0.9623 | EA | Generic | — | 2026-06-17 |
| 64950020610HYDROCODONE-HOMATROPINE 5-1.5 MG TABLET | $0.9623 | EA | Generic | — | 2026-06-17 |
| 64950037147HYDROCODONE-HOMATROPINE SOLN | $0.1005 | ML | 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.