Lincomycin Injectable Solution

Brand(s)
Lincocin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2015-11-18)
Oldest Current Product
1964-12-29
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\LINCOMYCIN
FDAOB
INJECTION\INJECTION\LINCOMYCIN HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\LINCOMYCIN HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\LINCOMYCIN

product(s) by strength(s)

lincomycin 300 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090555LincocinNDAPharmacia And Upjohn Company1964-12-29LINCOMYCIN HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA050317c01906fa-2c73-4c13-9765-2fd06628d263

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1398220350ANDAX-Gen Pharmaceuticals, Inc.2015-07-05LINCOMYCIN HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA20174661f4851d-d919-400d-912a-05eb9dca11d4
2398220353ANDAX-Gen Pharmaceuticals, Inc.2015-07-05LINCOMYCIN HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA20174661f4851d-d919-400d-912a-05eb9dca11d4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA063180LINCOMYCIN HYDROCHLORIDETrueWATSON LABORATORIES INC1991-04-16ANDA063180_001
2ANDA201746LINCOMYCINX-GEN PHARMACEUTICALS INC2015-06-04ANDA201746_001
3NDA050317LINCOCINPHARMACIA AND UPJOHN CONDA050317_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA063180_001discontinuedLINCOMYCIN HYDROCHLORIDE (EQ 300MG BASE/ML)INJECTIONFalse1991-04-16LINCOMYCIN HYDROCHLORIDE
2ANDA201746_001RXLINCOMYCIN HYDROCHLORIDE (EQ 300MG BASE/ML)INJECTIONFalseAP2015-06-04LINCOMYCIN
3NDA050317_001RXLINCOMYCIN HYDROCHLORIDE (EQ 300MG BASE/ML)INJECTIONTrueAPLINCOCIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
161f4851d-d919-400d-912a-05eb9dca11d4 (view SPL)Lincomycin Injection, USPprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2015-10-094398220350, 398220353
2c01906fa-2c73-4c13-9765-2fd06628d263 (view SPL)Lincocin lincomycin injection, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-11-1811000090555

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