DETRUSITOL SR- tolterodine tartrate capsule, extended release
Neolpharma, Inc.

----------

Detrusitol SR 4mg, Neolpharma as CMO

4mg 1s blister

4mg 1s carton

4mg 7s blister

4mg 7s carton

DETRUSITOL SR
tolterodine tartrate capsule, extended release

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOLTERODINE TARTRATE (UNII: 5T619TQR3R) (TOLTERODINE - UNII:WHE7A56U7K)	TOLTERODINE TARTRATE	4 mg

Ingredient Name	Strength
Inactive Ingredients
OLEIC ACID (UNII: 2UMI9U37CP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SUCROSE (UNII: C151H8M554)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
GELATIN (UNII: 2G86QN327L)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55466-716-70	1 in 1 CARTON	02/22/2000
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:55466-716-73	14 in 1 CARTON	02/22/2000
2		7 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	NDA021228	02/22/2000

Labeler - Neolpharma, Inc. (078709787)

Registrant - Neolpharma, Inc. (078709787)

Name	Address	ID/FEI	Business Operations
Establishment
Neolpharma, Inc.		078709787	pack(55466-716) , label(55466-716)

Name	Address	ID/FEI	Business Operations
Establishment
Catalent Pharma Solutions LLC		829672745	manufacture(55466-716) , analysis(55466-716)

Revised: 10/2017

Document Id: 5cdc0e09-73b6-4d8e-e053-2a91aa0accfc

Set id: 5c36d62b-5e24-9059-e053-2a91aa0ac32f

Version: 3

Effective Time: 20171031

Neolpharma, Inc.