Details for New Drug Application (NDA): 021427
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NDA 021427 describes CYMBALTA, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. Additional details are available on the CYMBALTA profile page.
The generic ingredient in CYMBALTA is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
The generic ingredient in CYMBALTA is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 021427
| Tradename: | CYMBALTA |
| Applicant: | Lilly |
| Ingredient: | duloxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021427
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 021427
Suppliers and Packaging for NDA: 021427
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427 | NDA | Eli Lilly and Company | 0002-3235 | 0002-3235-60 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3235-60) |
| CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427 | NDA | Eli Lilly and Company | 0002-3240 | 0002-3240-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3240-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Aug 3, 2004 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Aug 3, 2004 | TE: | AB | RLD: | Yes | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Aug 3, 2004 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021427
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-001 | Aug 3, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-002 | Aug 3, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-002 | Aug 3, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-004 | Aug 3, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-004 | Aug 3, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-004 | Aug 3, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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