Drug information for TRELSTAR
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; INTRAMUSCULAR
EQ 3.75MG BASE/VIAL
Prescription
(Reference Drug)
TRIPTORELIN PAMOATE
WATSON LABS
20715
2011-12-20 Other Important Information from FDA
2011-05-24 Letter
2011-05-23 Label
2011-01-20 Letter
2011-01-20 Label
2008-04-16 Letter
2005-10-25 Letter
2002-07-31 Review
2002-01-15 Letter
2002-01-15 Letter
2000-06-15 Letter
2000-06-15 Label
INJECTABLE; INTRAMUSCULAR
EQ 11.25MG BASE/VIAL
Prescription
(Reference Drug)
TRIPTORELIN PAMOATE
WATSON LABS
21288
2011-12-20 Other Important Information from FDA
2011-05-24 Letter
2011-05-23 Label
2011-01-20 Letter
2011-01-20 Label
2008-04-16 Letter
2005-10-25 Letter
2002-01-07 Review
2001-06-29 Label
2001-06-29 Letter
INJECTABLE; INTRAMUSCULAR
EQ 22.5MG BASE/VIAL
Prescription
(Reference Drug)
TRIPTORELIN PAMOATE
Triptorelin Pamoate
WATSON LABS
22437
2011-12-20 Other Important Information from FDA
2011-05-24 Letter
2011-05-23 Label
2011-02-17 Summary Review
2011-01-20 Letter
2011-01-20 Label
2010-11-10 Review
2010-03-18 Letter
2010-03-17 Label
Drug Adverse Effects information for TRELSTAR
Role code
Indications
Reaction
# Reports
PS
ANTIANDROGEN THERAPY
THROMBOCYTOPENIA
1
PS
BREAST CANCER
CERVICAL POLYP
2
PS
BREAST CANCER
FRACTURE
1
PS
BREAST CANCER FEMALE
UPPER LIMB FRACTURE
2
PS
PAEDOPHILIA
DEATH
1
PS
PAEDOPHILIA
SCIATICA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ANGINA PECTORIS
3
PS
PRODUCT USED FOR UNKNOWN INDICATION
INGUINAL HERNIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
THROMBOCYTOPENIA
3
PS
PROSTATE CANCER
ANGINA PECTORIS
1
PS
PROSTATE CANCER
INGUINAL HERNIA
1
SS
PROSTATE CANCER
NEOPLASM MALIGNANT
1
C
METASTASES TO BONE
DISEASE PROGRESSION
1
C
METASTASES TO BONE
DYSPHAGIA
1
C
METASTASES TO BONE
MUSCULOSKELETAL DISCOMFORT
1
C
PROSTATE CANCER
CARDIAC FAILURE
1
C
PROSTATE CANCER
COUGH
1
C
PROSTATE CANCER
DECREASED APPETITE
1
C
PROSTATE CANCER
DYSPNOEA
2
C
PROSTATE CANCER
PNEUMONIA
1
C
PROSTATE CANCER METASTATIC
DISEASE PROGRESSION
2
C
PROSTATE CANCER METASTATIC
DYSPHAGIA
2
C
PROSTATE CANCER METASTATIC
MEMORY IMPAIRMENT
1
C
PROSTATE CANCER METASTATIC
MUSCULOSKELETAL DISCOMFORT
2
C
PROSTATE CANCER METASTATIC
NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL
1
C
PROSTATE CANCER METASTATIC
TRANSIENT ISCHAEMIC ATTACK
1
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