Dextromethorphan hydrobromide; promethazine hydrochloride - Generic Drug Details
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What are the generic sources for dextromethorphan hydrobromide; promethazine hydrochloride and what is the scope of freedom to operate?
Dextromethorphan hydrobromide; promethazine hydrochloride
is the generic ingredient in five branded drugs marketed by Halsey, G And W Labs Inc, Slate Run Pharma, Amneal Pharms, Ani Pharms, Hikma, Tris Pharma Inc, and Wockhardt Bio Ag, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.Eleven suppliers are listed for this compound.
Summary for dextromethorphan hydrobromide; promethazine hydrochloride
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 8 |
NDAs: | 8 |
Finished Product Suppliers / Packagers: | 11 |
DailyMed Link: | dextromethorphan hydrobromide; promethazine hydrochloride at DailyMed |
Pharmacology for dextromethorphan hydrobromide; promethazine hydrochloride
Drug Class | Phenothiazine Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist |
Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for dextromethorphan hydrobromide; promethazine hydrochloride
US Patents and Regulatory Information for dextromethorphan hydrobromide; promethazine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Wockhardt Bio Ag | PROMETHAZINE W/ DEXTROMETHORPHAN | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 088864-001 | Jan 4, 1985 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
G And W Labs Inc | PROMETH W/ DEXTROMETHORPHAN | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 088762-001 | Oct 31, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 040027-001 | Jul 31, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Tris Pharma Inc | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 091687-001 | Jun 28, 2012 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Slate Run Pharma | PROMETHAZINE DM | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 040649-001 | Feb 14, 2006 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Halsey | PHERAZINE DM | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 088913-001 | Mar 2, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ani Pharms | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 011265-002 | Apr 2, 1984 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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