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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207724
Company: AMNEAL PHARMS NY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROGESTERONE PROGESTERONE 100MG CAPSULE;ORAL Prescription AB No No
PROGESTERONE PROGESTERONE 200MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/07/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

PROGESTERONE

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGESTERONE PROGESTERONE 100MG CAPSULE;ORAL Prescription No AB 207724 AMNEAL PHARMS NY
PROGESTERONE PROGESTERONE 100MG CAPSULE;ORAL Prescription No AB 200900 BIONPHARMA INC
PROGESTERONE PROGESTERONE 100MG CAPSULE;ORAL Prescription No AB 208801 DR REDDYS
PROGESTERONE PROGESTERONE 100MG CAPSULE;ORAL Prescription No AB 211285 EUGIA PHARMA
PROGESTERONE PROGESTERONE 100MG CAPSULE;ORAL Prescription No AB 205229 XIROMED
PROMETRIUM PROGESTERONE 100MG CAPSULE;ORAL Prescription Yes AB 019781 VIRTUS PHARMS

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGESTERONE PROGESTERONE 200MG CAPSULE;ORAL Prescription No AB 207724 AMNEAL PHARMS NY
PROGESTERONE PROGESTERONE 200MG CAPSULE;ORAL Prescription No AB 200900 BIONPHARMA INC
PROGESTERONE PROGESTERONE 200MG CAPSULE;ORAL Prescription No AB 208801 DR REDDYS
PROGESTERONE PROGESTERONE 200MG CAPSULE;ORAL Prescription No AB 211285 EUGIA PHARMA
PROGESTERONE PROGESTERONE 200MG CAPSULE;ORAL Prescription No AB 205229 XIROMED
PROMETRIUM PROGESTERONE 200MG CAPSULE;ORAL Prescription Yes AB 019781 VIRTUS PHARMS
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