Progesterone Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2015-07-13)
Oldest Current Product
1978-05-11
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\PROGESTERONE
FDAOB
INJECTION\INJECTION\PROGESTERONE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\PROGESTERONE
INTRAMUSCULAR\INJECTION\PROGESTERONE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\PROGESTERONE
INTRAMUSCULAR\INJECTION\PROGESTERONE

product(s) by strength(s)

progesterone 50 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913128NDAWatson Laboratories, Inc.1978-05-11PROGESTERONEINTRAMUSCULARINJECTION, SOLUTIONNDA017362a09a3b76-36f1-4d20-930e-7e3da97e7ebd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439725ANDAWest-Ward Pharmaceutical Corp2010-10-28PROGESTERONEINTRAMUSCULARINJECTIONANDA09103383cfc12e-75d1-4284-bcc3-beadcbd27171
2005170750ANDAAmerican Regent, Inc.2010-09-29PROGESTERONEINTRAMUSCULARINJECTION, SOLUTIONANDA090845b79abe4a-0242-41da-b91b-df723b85f0cc
3633230261ANDAApp Pharmaceuticals, Llc2001-07-19PROGESTERONEINTRAMUSCULARINJECTION, SOLUTIONANDA075906a479b395-1e1a-4d2a-8feb-68a15c47225f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075906PROGESTERONEFRESENIUS KABI USA LLC2001-04-25ANDA075906_001
2ANDA090845PROGESTERONELUITPOLD PHARMACEUTICALS INC2009-06-22ANDA090845_001
3ANDA091033PROGESTERONEHIKMA FARMACEUTICA (PORTUGAL) SA2010-10-28ANDA091033_001
4NDA009238PROGESTERONETrueELI LILLY AND CONDA009238_001, NDA009238_002
5NDA017362PROGESTERONEACTAVIS LABORATORIES UT INCNDA017362_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075906_001RXPROGESTERONE (50MG/ML)INJECTIONFalseAO2001-04-25PROGESTERONE
2ANDA090845_001RXPROGESTERONE (50MG/ML)INJECTIONFalseAO2009-06-22PROGESTERONE
3ANDA091033_001RXPROGESTERONE (50MG/ML)INJECTIONFalseAO2010-10-28PROGESTERONE
4NDA009238_001discontinuedPROGESTERONE (50MG/ML)INJECTIONFalsePROGESTERONE
5NDA009238_002discontinuedPROGESTERONE (25MG/ML)INJECTIONFalsePROGESTERONE
6NDA017362_002RXPROGESTERONE (50MG/ML)INJECTIONTrueAOPROGESTERONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
183cfc12e-75d1-4284-bcc3-beadcbd27171 (view SPL)PROGESTERONE INJECTION, USP IN SESAME OIL FOR INTRAMUSCULAR USE ONLYRx onlyprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2010-12-022001439725
2a09a3b76-36f1-4d20-930e-7e3da97e7ebd (view SPL)PROGESTERONE INJECTION USP IN SESAME OIL FOR INTRAMUSCULAR USE ONLY Rx only Content Updated: September 2014prescriptionHuman PrescriptionWatson Laboratories, Inc.2015-07-1317005913128
3a479b395-1e1a-4d2a-8feb-68a15c47225f (view SPL)Progesterone Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-01-062633230261
4b79abe4a-0242-41da-b91b-df723b85f0cc (view SPL)PROGESTERONE INJECTION, USP IN SESAME OILprescriptionHuman PrescriptionAmerican Regent, Inc.2010-09-301005170750

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII