Application 207799

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	CAPSULE;ORAL	75MG	No	No
002	PREGABALIN	PREGABALIN	CAPSULE;ORAL	100MG	No	No
003	PREGABALIN	PREGABALIN	CAPSULE;ORAL	150MG	No	No
004	PREGABALIN	PREGABALIN	CAPSULE;ORAL	200MG	No	No
005	PREGABALIN	PREGABALIN	CAPSULE;ORAL	225MG	No	No
006	PREGABALIN	PREGABALIN	CAPSULE;ORAL	300MG	No	No
007	PREGABALIN	PREGABALIN	CAPSULE;ORAL	25MG	No	No
008	PREGABALIN	PREGABALIN	CAPSULE;ORAL	50MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-462	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-463	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-464	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-464	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-464	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-465	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-465	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-465	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-466	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-466	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-466	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-467	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-467	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-467	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-468	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-468	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-468	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-469	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-469	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-469	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
70518-3597	Pregabalin	Pregabalin	REMEDYREPACK INC.	ANDA	Current
71205-608	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71205-608	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71205-621	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71205-621	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71205-639	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71205-639	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71335-1740	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1740	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1745	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1745	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1758	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1758	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
80425-0160	Lyrica	Pregabalin 300mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0160	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0160	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0160	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0185	PREGABALIN	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0185	PREGABALIN	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Application 207799

Related Records#

Application Products#

NDC Listings For This Application#