Promazine hydrochloride - Generic Drug Details
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What are the generic sources for promazine hydrochloride and what is the scope of patent protection?
Promazine hydrochloride
is the generic ingredient in two branded drugs marketed by Wyeth Ayerst, Watson Labs, and Hikma, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are sixteen drug master file entries for promazine hydrochloride.
Summary for promazine hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 5 |
| Drug Master File Entries: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 77 |
| Clinical Trials: | 1 |
| Patent Applications: | 636 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | promazine hydrochloride at DailyMed |
Recent Clinical Trials for promazine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Richever Enterprise Co., Ltd. | Phase 3 |
Medical Subject Heading (MeSH) Categories for promazine hydrochloride
US Patents and Regulatory Information for promazine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wyeth Ayerst | SPARINE | promazine hydrochloride | TABLET;ORAL | 010348-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | SPARINE | promazine hydrochloride | INJECTABLE;INJECTION | 010349-008 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Wyeth Ayerst | SPARINE | promazine hydrochloride | TABLET;ORAL | 010348-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Wyeth Ayerst | SPARINE | promazine hydrochloride | CONCENTRATE;ORAL | 010942-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Watson Labs | PROMAZINE HYDROCHLORIDE | promazine hydrochloride | INJECTABLE;INJECTION | 084510-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Wyeth Ayerst | SPARINE | promazine hydrochloride | TABLET;ORAL | 010348-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
