Approved Drug Products containing 21443 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 21443

Aspen Pharmacare Holdings, based in South Africa, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ESTROGENS, CONJUGATED SYNTHETIC B, with a corresponding application number 21443.

Regulatory Information DISCN

With a dosage strength 0.45MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2004-12-20

Aspen Pharmacare Holdings, based in South Africa, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ESTROGENS, CONJUGATED SYNTHETIC B, with a corresponding application number 21443.

Regulatory Information DISCN

With a dosage strength 0.9MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2007-04-27

Aspen Pharmacare Holdings, based in South Africa, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ESTROGENS, CONJUGATED SYNTHETIC B, with a corresponding application number 21443.

Regulatory Information DISCN

With a dosage strength 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2004-05-10

Aspen Pharmacare Holdings, based in South Africa, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ESTROGENS, CONJUGATED SYNTHETIC B, with a corresponding application number 21443.

Regulatory Information DISCN

With a dosage strength 0.3MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2004-12-20

score 19 · Accepted Answer

Aspen Pharmacare Holdings, based in South Africa, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ESTROGENS, CONJUGATED SYNTHETIC B, with a corresponding application number 21443.

Regulatory Information DISCN

With a dosage strength 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2004-05-10

Approved Drug Products containing 21443 listed in the FDA Orange Book. Original Data : FDA Website

Aspen Pharmacare Holdings

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TABLET; ORAL

1.25MG **Federal R...

2004-05-10

21443

ENJUVIA

DISCN

No

TABLET; ORAL

0.45MG

2004-12-20

21443

ENJUVIA

DISCN

No

TABLET; ORAL

0.9MG

2007-04-27

21443

ENJUVIA

DISCN

No

TABLET; ORAL

0.625MG **Federal ...

2004-05-10

21443

ENJUVIA

DISCN

No

TABLET; ORAL

0.3MG

2004-12-20

21443

ENJUVIA

DISCN

No

Looking for FDA Orange Book APPLICATION 21443