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Approved Drug Products containing 21272 listed in the FDA Orange Book. Original Data : FDA Website

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01 UNITED THERAP (8)

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01 INJECTABLE;IV (INFUSION), SUBCUTANEOUS (8)

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01 RX (8)

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01 REMODULIN (8)

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01 Yes (8)

URL Supplier Web Content
INJECTABLE; IV (IN...
0.1MG/ML
2023-09-28
21272
REMODULIN
RX
Yes
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INJECTABLE; IV (IN...
10MG/ML
2002-05-21
21272
REMODULIN
RX
Yes
AP
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INJECTABLE; IV (IN...
2.5MG/ML
2002-05-21
21272
REMODULIN
RX
Yes
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INJECTABLE; IV (IN...
0.2MG/ML
2023-09-28
21272
REMODULIN
RX
Yes
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INJECTABLE; IV (IN...
20MG/ML
2021-07-30
21272
REMODULIN
RX
Yes
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INJECTABLE; IV (IN...
5MG/ML
2002-05-21
21272
REMODULIN
RX
Yes
AP
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INJECTABLE; IV (IN...
1MG/ML
2002-05-21
21272
REMODULIN
RX
Yes
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INJECTABLE; IV (IN...
0.4MG/ML
2023-09-28
21272
REMODULIN
RX
Yes
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Looking for FDA Orange Book APPLICATION 21272

Looking for FDA Orange Book APPLICATION 21272 8

19

United Therapeutics, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TREPROSTINIL, with a corresponding application number 21272.

Regulatory Information RX

With a dosage strength 0.1MG/ML

Dosage Form Route INJECTABLE; IV (INFUSION), SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2023-09-28

18

United Therapeutics, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TREPROSTINIL, with a corresponding application number 21272.

Regulatory Information RX

With a dosage strength 10MG/ML

Dosage Form Route INJECTABLE; IV (INFUSION), SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2002-05-21

Therapeutic Equivalence (TE) Code AP

17

United Therapeutics, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TREPROSTINIL, with a corresponding application number 21272.

Regulatory Information RX

With a dosage strength 2.5MG/ML

Dosage Form Route INJECTABLE; IV (INFUSION), SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2002-05-21

Therapeutic Equivalence (TE) Code AP

16

United Therapeutics, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TREPROSTINIL, with a corresponding application number 21272.

Regulatory Information RX

With a dosage strength 0.2MG/ML

Dosage Form Route INJECTABLE; IV (INFUSION), SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2023-09-28

15

United Therapeutics, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TREPROSTINIL, with a corresponding application number 21272.

Regulatory Information RX

With a dosage strength 20MG/ML

Dosage Form Route INJECTABLE; IV (INFUSION), SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2021-07-30

14

United Therapeutics, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TREPROSTINIL, with a corresponding application number 21272.

Regulatory Information RX

With a dosage strength 5MG/ML

Dosage Form Route INJECTABLE; IV (INFUSION), SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2002-05-21

Therapeutic Equivalence (TE) Code AP

13

United Therapeutics, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TREPROSTINIL, with a corresponding application number 21272.

Regulatory Information RX

With a dosage strength 1MG/ML

Dosage Form Route INJECTABLE; IV (INFUSION), SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2002-05-21

Therapeutic Equivalence (TE) Code AP

12

United Therapeutics, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TREPROSTINIL, with a corresponding application number 21272.

Regulatory Information RX

With a dosage strength 0.4MG/ML

Dosage Form Route INJECTABLE; IV (INFUSION), SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2023-09-28

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