← FDA Drug Approvals (Drugs@FDA)
TEMOZOLOMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2014-02-12
Drug application
- FDA Application #
ANDA201742
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- TEMOZOLOMIDE
- Generic name
- TEMOZOLOMIDE
- Active ingredients
- TEMOZOLOMIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SUN PHARM
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- First approval
- 2014-02-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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