Details for New Drug Application (NDA): 021332
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The generic ingredient in SYMLIN is pramlintide acetate. There are three drug master file entries for this compound. Additional details are available on the pramlintide acetate profile page.
Summary for 021332
Tradename: | SYMLIN |
Applicant: | Astrazeneca Ab |
Ingredient: | pramlintide acetate |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) | ||||
Approval Date: | Mar 16, 2005 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) | ||||
Approval Date: | Sep 25, 2007 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) | ||||
Approval Date: | Sep 25, 2007 | TE: | RLD: | Yes |
Expired US Patents for NDA 021332
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-003 | Sep 25, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-001 | Mar 16, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-003 | Sep 25, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-002 | Sep 25, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-003 | Sep 25, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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