# NIFEDIPINE
> **ANDA077127** · Abbreviated New Drug Application (Generic) · Sponsor: OSMOTICA PHARM US · Approved 2005-11-21
## Drug
- **FDA Application Number:** ANDA077127
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** NIFEDIPINE
- **Generic name:** NIFEDIPINE
- **Active ingredients:** NIFEDIPINE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** OSMOTICA PHARM US
- **Manufacturer:** Chartwell RX, LLC
- **First approval:** 2005-11-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077127)
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*MORVS · CC0 1.0*