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PERGOLIDE MESYLATE

ANDA

PERGOLIDE MESYLATE | A076061 | STRIDES PHARMA GLOBAL PTE LTD

3 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petiton from Kindred Biosciences Inc FDA-2017-P-4255 · 6 docket documents Kindred Biosciences Inc. filed a petition under 21 U.S.C. 360b(n)(3) requesting a change in dosage form for pergolide mesylate from the reference labeled new animal drug Prascend (NADA 141-331), a tablet, to an immediate-release extruded pellet top-dress formulation for oral administration to horses	Other	2017-07-17	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain1 active DMF3 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

OLON SPAPERGOLIDE MESYLATE

DMF 179822005

BACHEM SAInactivePERGOLIDE MESYLATE

DMF 150132000

GALENA ASInactivePERGOLIDE MESYLATE

DMF 151802000

TEVA PHARMACEUTICAL INDUSTRIES LTDInactivePERGOLIDE MESYLATE

DMF 243232010

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

Products (3)

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#001 — EQ 0.05MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 27, 2002

No patent or exclusivity listings for this strength.

#002 — EQ 0.25MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 27, 2002

#003 — EQ 1MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 27, 2002