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FDA ANDA · ANDA084754

DEXAMETHASONE

Sponsor: KANCHAN HLTHCARE

APPLICATION
ANDA084754
TYPE
ANDA
ORIGINAL APPROVAL
1976-09-21
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Prescription

Products

DEXAMETHASONEPrescription
DEXAMETHASONE 0.5MG/5ML · ELIXIR · ORAL

Approval history

2024-06-05Labeling · Supplement 61 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 51AP
1995-10-27Manufacturing (CMC) · Supplement 48AP
1995-06-02Labeling · Supplement 47AP
1994-05-25Labeling · Supplement 45AP
1992-07-20Labeling · Supplement 44AP
1991-10-28Labeling · Supplement 38AP
1991-05-31Manufacturing (CMC) · Supplement 42AP
1991-05-02Manufacturing (CMC) · Supplement 41AP
1990-09-28Manufacturing (CMC) · Supplement 40AP
1990-04-05Labeling · Supplement 37AP
1990-01-04Labeling · Supplement 39AP
1989-03-28Manufacturing (CMC) · Supplement 33AP
1989-02-08Manufacturing (CMC) · Supplement 35AP
1989-02-08Manufacturing (CMC) · Supplement 36AP
1989-02-08Manufacturing (CMC) · Supplement 34AP
1988-05-13Labeling · Supplement 32AP
1982-10-08Manufacturing (CMC) · Supplement 28AP
1982-09-01Manufacturing (CMC) · Supplement 29AP
1976-09-21OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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