Details for New Drug Application (NDA): 017563
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NDA 017563 describes FLAVORED COLESTID, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. Additional details are available on the FLAVORED COLESTID profile page.
The generic ingredient in FLAVORED COLESTID is colestipol hydrochloride. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the colestipol hydrochloride profile page.
The generic ingredient in FLAVORED COLESTID is colestipol hydrochloride. There are two drug master file entries for this compound. Seven 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 |
| Formulation / Manufacturing: | see details |
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 | 0009-0260-01 | 30 PACKET in 1 CARTON (0009-0260-01) / 5 g in 1 PACKET |
| 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | 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: | RX | 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | FLAVORED COLESTID | colestipol hydrochloride | GRANULE;ORAL | 017563-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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