Orange Book product · Brand (NDA)

PREMPHASE 14/14

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Brand (NDA)NDA 020527RX WYETH PHARMS

View ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE family Open on FDA Orange Book

At a glance

Nov 17, 1995

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Nov 17, 1995
31 yr ago
Today

Pharmaceutical detail

Active ingredient

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Strength

0.625MG,0.625MG;N/A,5MG

Dosage form

TABLET

Route

ORAL-28

TE code

Not listed

Application

NDA 020527

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

PREMPHASE (PREMARIN;CYCRIN 14/14)Brand (NDA)
NDA 020303 · WYETH PHARMS INC
1994

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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