Details for New Drug Application (NDA): 021107
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The generic ingredient in LOTRONEX is alosetron hydrochloride. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the alosetron hydrochloride profile page.
Summary for 021107
Tradename: | LOTRONEX |
Applicant: | Sebela Ireland Ltd |
Ingredient: | alosetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 021107
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 021107
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 45963-479 | 45963-479-03 | 1 BOTTLE in 1 CARTON (45963-479-03) / 30 TABLET in 1 BOTTLE |
LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 45963-480 | 45963-480-03 | 1 BOTTLE in 1 CARTON (45963-480-03) / 30 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Feb 9, 2000 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
Approval Date: | Dec 23, 2003 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021107
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-002 | Dec 23, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-001 | Feb 9, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-001 | Feb 9, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-002 | Dec 23, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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