FDA.reportPublic FDA data

Application 062756

Type
ANDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRIMAXINCILASTATIN SODIUM; IMIPENEMINJECTABLE;INJECTIONEQ 250MG BASE/VIAL;250MG/VIALNoNo
002PRIMAXINCILASTATIN SODIUM; IMIPENEMINJECTABLE;INJECTIONEQ 500MG BASE/VIAL;500MG/VIALNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42775SUPPL2007-11-19
42774SUPPL2007-11-19
42773SUPPL2007-11-19
42763SUPPL2007-11-19
22290SUPPL2007-11-19
22289SUPPL2007-11-19
22288SUPPL2007-11-19
22284SUPPL2007-11-19
22274SUPPL2007-11-19
22272SUPPL2007-11-19
22271SUPPL2007-11-19
42772SUPPL2007-09-26
42771SUPPL2007-09-26
42770SUPPL2007-09-26
42769SUPPL2007-09-26
42768SUPPL2007-09-26
42767SUPPL2007-09-26
42766SUPPL2007-09-26
22287SUPPL2007-09-26
22286SUPPL2007-09-26
22285SUPPL2007-09-26
22283SUPPL2007-09-26
22281SUPPL2007-09-26
22280SUPPL2007-09-26
22279SUPPL2007-09-26
22278SUPPL2007-09-26
22277SUPPL2007-09-26
22276SUPPL2007-09-26
22282SUPPL2007-09-13
42765SUPPL2007-08-06
42764SUPPL2007-08-06
22275SUPPL2007-08-06
22273SUPPL2007-08-06