Details for New Drug Application (NDA): 021256
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NDA 021256 describes CHIRHOSTIM, which is a drug marketed by Chirhoclin and is included in one NDA. It is available from one supplier. Additional details are available on the CHIRHOSTIM profile page.
The generic ingredient in CHIRHOSTIM is secretin synthetic human. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the secretin synthetic human profile page.
The generic ingredient in CHIRHOSTIM is secretin synthetic human. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the secretin synthetic human profile page.
Summary for 021256
| Tradename: | CHIRHOSTIM |
| Applicant: | Chirhoclin |
| Ingredient: | secretin synthetic human |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021256
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHIRHOSTIM | secretin synthetic human | FOR SOLUTION;INTRAVENOUS | 021256 | NDA | ChiRhoClin, Inc. | 67066-005 | 67066-005-01 | 8 mL in 1 VIAL, SINGLE-USE (67066-005-01) |
| CHIRHOSTIM | secretin synthetic human | FOR SOLUTION;INTRAVENOUS | 021256 | NDA | ChiRhoClin, Inc. | 67066-007 | 67066-007-01 | 10 mL in 1 VIAL, SINGLE-USE (67066-007-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;INTRAVENOUS | Strength | 16MCG/VIAL | ||||
| Approval Date: | Apr 9, 2004 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;INTRAVENOUS | Strength | 40MCG/VIAL | ||||
| Approval Date: | Jun 21, 2007 | TE: | RLD: | Yes | |||||
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