Details for New Drug Application (NDA): 018936
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The generic ingredient in SARAFEM is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 018936
Tradename: | SARAFEM |
Applicant: | Eli Lilly And Co |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 018936
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 018936
Suppliers and Packaging for NDA: 018936
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROZAC | fluoxetine hydrochloride | CAPSULE;ORAL | 018936 | NDA | Dista Products Company | 0777-3104 | 0777-3104-02 | 100 CAPSULE in 1 BOTTLE (0777-3104-02) |
SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936 | NDA | Dista Products Company | 0777-3104 | 0777-3104-02 | 100 CAPSULE in 1 BOTTLE (0777-3104-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Dec 29, 1987 | TE: | AB1 | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Jun 15, 1999 | TE: | AB | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 60MG BASE | ||||
Approval Date: | Jun 15, 1999 | TE: | RLD: | No |
Expired US Patents for NDA 018936
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Eli Lilly And Co | PROZAC | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-001 | Dec 29, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Eli Lilly And Co | PROZAC | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-001 | Dec 29, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Eli Lilly And Co | PROZAC | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-001 | Dec 29, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Eli Lilly And Co | PROZAC | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-006 | Dec 23, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-007 | Jul 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Eli Lilly And Co | PROZAC | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-003 | Jun 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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