PROMETHAZINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for promethazine hydrochloride and what is the scope of freedom to operate?
Promethazine hydrochloride
is the generic ingredient in thirteen branded drugs marketed by Wyeth Ayerst, Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt, Xgen Pharms, Altana, Norvium Bioscience, Polymedica, Able, Annora Pharma, Cosette, Padagis Israel, Taro, Watson Labs Inc, Usl Pharma, Alpharma Us Pharms, Actavis Mid Atlantic, Cenci, Amneal Pharms, Chartwell Rx, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Ani Pharms, Wockhardt Bio Ag, Delcor Asset Corp, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, and Bristol Myers Squibb, and is included in eighty-nine NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for promethazine hydrochloride. Forty-nine suppliers are listed for this compound.
Summary for PROMETHAZINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 13 |
Applicants: | 54 |
NDAs: | 89 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 49 |
Raw Ingredient (Bulk) Api Vendors: | 94 |
Clinical Trials: | 58 |
Patent Applications: | 4,150 |
What excipients (inactive ingredients) are in PROMETHAZINE HYDROCHLORIDE? | PROMETHAZINE HYDROCHLORIDE excipients list |
DailyMed Link: | PROMETHAZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PROMETHAZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Trauma Center | N/A |
Oman Medical Speciality Board | Phase 3 |
Tanta University | N/A |
Pharmacology for PROMETHAZINE HYDROCHLORIDE
Drug Class | Phenothiazine |
Medical Subject Heading (MeSH) Categories for PROMETHAZINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for PROMETHAZINE HYDROCHLORIDE
US Patents and Regulatory Information for PROMETHAZINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell Molecular | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 080949-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Impax Labs | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 040791-003 | Feb 12, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Able | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 040558-003 | Jul 1, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Quagen | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 040673-001 | Mar 5, 2008 | AB | RX | No | 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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