Ranitidine - Generic Drug Details
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Summary for ranitidine
US Patents: | 0 |
Tradenames: | 9 |
Applicants: | 48 |
NDAs: | 85 |
Drug Master File Entries: | 43 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Clinical Trials: | 111 |
Patent Applications: | 5 |
Drug Prices: | Drug price trends for ranitidine |
Drug Sales Revenues: | Drug sales revenues for ranitidine |
What excipients (inactive ingredients) are in ranitidine? | ranitidine excipients list |
DailyMed Link: | ranitidine at DailyMed |
Recent Clinical Trials for ranitidine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Menoufia University | Phase 2/Phase 3 |
Cairo University | N/A |
University of Sao Paulo General Hospital | Phase 3 |
Generic filers with tentative approvals for RANITIDINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 15MG/ML | Solution; Oral |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for ranitidine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Strides Pharma | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 209160-001 | Mar 5, 2018 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amneal Pharms | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | SYRUP;ORAL | 078312-001 | Sep 2, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Nostrum Labs Inc | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 203694-002 | Nov 30, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pai Holdings Pharm | ZANTAC | ranitidine hydrochloride | INJECTABLE;INJECTION | 019090-001 | Oct 19, 1984 | DISCN | Yes | 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 |