Details for New Drug Application (NDA): 017563
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The generic ingredient in FLAVORED COLESTID is colestipol hydrochloride. There are two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the colestipol hydrochloride profile page.
Summary for 017563
Tradename: | FLAVORED COLESTID |
Applicant: | Pfizer |
Ingredient: | colestipol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 017563
Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 017563
Suppliers and Packaging for NDA: 017563
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLESTID | colestipol hydrochloride | GRANULE;ORAL | 017563 | NDA | Pharmacia & Upjohn Company LLC | 0009-0260 | 0009-0260-02 | 1 BOTTLE in 1 CARTON (0009-0260-02) / 500 g in 1 BOTTLE |
COLESTID | colestipol hydrochloride | GRANULE;ORAL | 017563 | NDA | Pharmacia & Upjohn Company LLC | 0009-0260 | 0009-0260-04 | 90 PACKET in 1 CARTON (0009-0260-04) / 5 g in 1 PACKET |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | GRANULE;ORAL | Strength | 5GM/PACKET | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | GRANULE;ORAL | Strength | 5GM/SCOOPFUL | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 5GM/SCOOPFUL | ||||
Approval Date: | Sep 22, 1995 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 017563
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | FLAVORED COLESTID | colestipol hydrochloride | GRANULE;ORAL | 017563-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | FLAVORED COLESTID | colestipol hydrochloride | GRANULE;ORAL | 017563-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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