← FDA Drug Approvals (Drugs@FDA)
DICLOFENAC SODIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2016-09-13
Drug application
- FDA Application #
ANDA208301
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DICLOFENAC SODIUM
- Generic name
- DICLOFENAC SODIUM
- Active ingredients
- DICLOFENAC SODIUM
- Dosage form
- GEL
- Route
- TOPICAL
- Marketing status
- Prescription
- Sponsor
- GLENMARK PHARMS LTD
- Manufacturer
- GLENMARK PHARMACEUTICALS INC., USA
- First approval
- 2016-09-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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