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ESTRADIOL VALERATE

ANDA

ESTRADIOL VALERATE | A090920 | AMERICAN REGENT INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DELESTROGEN(TE code: AO)

API Supply Chain5 active DMFs2 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

BAYER AGESTRADIOL VALERATE

DMF 33791978

ASPEN OSS BVESTRADIOL VALERATE

DMF 122681996

VALDEPHARMESTRADIOL VALERATE

DMF 239482010

LUPIN LTDESTRADIOL VALERATE USP

DMF 258542012

STEROID SPAESTRADIOL VALERATE

DMF 395942024

ROUSSELL UCLAFInactiveESTRADIOL VALERATE

DMF 30721977

GEDEON RICHTER PLCInactiveESTRADIOL VALERATE

DMF 245532011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — 20MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 19, 2010

No patent or exclusivity listings for this strength.

#002 — 40MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 19, 2010