Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Mahabubnagar, India | Makes it and tests it | No problems foundJan 18, 2023 · 2 inspections |
Recalls
- Apr 24, 2024 · Class II · Aurobindo Pharma USA Inc.
Discoloration: Dotted and yellow spots on tablets
Lots: Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025. - Apr 24, 2024 · Class II · Aurobindo Pharma USA Inc.
Discoloration: Dotted and yellow spots on tablets
Lots: Lot #s: a) CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025; b) CZB124001A, CZB124003A, Exp. 12/31/2025.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Clorazepic Acid: every company that makes it
- Form
- tablet, oral
- Strength
- 3.75 mg
- Approval
- ANDA ANDA071858
- On the market since
- Sep 23, 2023
- Package NDCs
13107-282-0113107-282-05- Official label
- DailyMed (National Library of Medicine), updated Jan 20, 2024
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