Purisys Llc

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2022-03-15

Pay. Date : 2022-03-10

DMF Number : 33223

Submission : 2019-02-22

Status : Active

Type : II

Product
Web Link

02

Dronabinol Drug Substance

U.S.A

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U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36220

Submission : 2021-10-12

Status : Active

Type : II

Product
Web Link

03

Dronabinol Drug Substance In Sesame ...

U.S.A

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U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2022-06-28

Pay. Date : 2022-06-23

DMF Number : 20682

Submission : 2007-07-16

Status : Active

Type : II

Product
Web Link

04

Dronabinol, 10% In Sesame Oil

U.S.A

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U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19335

Submission : 2006-04-07

Status : Active

Type : II

Product
Web Link

05

Nabilone Drug Substance

U.S.A

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U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35408

Submission : 2020-12-15

Status : Active

Type : II

Product
Web Link

06

Psilocybin

U.S.A

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U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37635

Submission : 2023-01-31

Status : Active

Type : II

Product
Web Link

07

Nalmefene Hydrochloride Drug Substan...

U.S.A

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U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39767

Submission : 2024-08-30

Status : Active

Type : II

Product
Web Link