Gentamicin sulfate - Generic Drug Details
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What are the generic sources for gentamicin sulfate and what is the scope of freedom to operate?
Gentamicin sulfate
is the generic ingredient in twelve branded drugs marketed by Schering, Pharmafair, Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Padagis Us, Pharmaderm, Taro, King Pharms, Bristol, Intl Medication, Abbott, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Kalapharm, Pharm Spec, Solopak, Teva Parenteral, Watson Labs, Wyeth Ayerst, B Braun, Baxter Hlthcare, Pharmacia And Upjohn, Novartis, Fera Pharms Llc, Sciegen Pharms Inc, Encube, Allergan, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Paco, and Sandoz, and is included in sixty-two NDAs. Additional information is available in the individual branded drug profile pages.There are fourteen drug master file entries for gentamicin sulfate. Twenty-seven suppliers are listed for this compound.
Summary for gentamicin sulfate
US Patents: | 0 |
Tradenames: | 12 |
Applicants: | 35 |
NDAs: | 62 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 27 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 13 |
Patent Applications: | 626 |
What excipients (inactive ingredients) are in gentamicin sulfate? | gentamicin sulfate excipients list |
DailyMed Link: | gentamicin sulfate at DailyMed |
Recent Clinical Trials for gentamicin sulfate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Oslo University Hospital | Phase 1/Phase 2 |
University of California, San Diego | Phase 2 |
Kaiser Permanente | Phase 2 |
Pharmacology for gentamicin sulfate
Drug Class | Aminoglycoside Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for gentamicin sulfate
US Patents and Regulatory Information for gentamicin sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
King Pharms | APOGEN | gentamicin sulfate | INJECTABLE;INJECTION | 062289-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hospira | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | gentamicin sulfate | INJECTABLE;INJECTION | 062414-002 | Aug 15, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Solopak | GENTAMICIN SULFATE | gentamicin sulfate | INJECTABLE;INJECTION | 062507-002 | Jun 6, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hospira | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | gentamicin sulfate | INJECTABLE;INJECTION | 062414-009 | Aug 15, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Solopak | GENTAMICIN SULFATE | gentamicin sulfate | INJECTABLE;INJECTION | 062507-001 | Jun 6, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
B Braun | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | gentamicin sulfate | INJECTABLE;INJECTION | 062814-005 | Aug 28, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
King Pharms | APOGEN | gentamicin sulfate | INJECTABLE;INJECTION | 062289-001 | Approved Prior to Jan 1, 1982 | DISCN | 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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