Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200456
Company: SOFGEN PHARMS
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
09/28/2012 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200456Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2013 SUPPL-1 Labeling-Package Insert

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 LABS INC
PROGESTERONE PROGESTERONE 100MG CAPSULE;ORAL Prescription No AB 211285 EUGIA PHARMA
PROGESTERONE PROGESTERONE 100MG CAPSULE;ORAL Prescription No AB 205229 SANDOZ INC
PROGESTERONE PROGESTERONE 100MG CAPSULE;ORAL Prescription No AB 200456 SOFGEN PHARMS
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 LABS INC
PROGESTERONE PROGESTERONE 200MG CAPSULE;ORAL Prescription No AB 211285 EUGIA PHARMA
PROGESTERONE PROGESTERONE 200MG CAPSULE;ORAL Prescription No AB 205229 SANDOZ INC
PROGESTERONE PROGESTERONE 200MG CAPSULE;ORAL Prescription No AB 200456 SOFGEN PHARMS
PROMETRIUM PROGESTERONE 200MG CAPSULE;ORAL Prescription Yes AB 019781 VIRTUS PHARMS

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