SEROMYCIN- cycloserine capsule
REMEDYREPACK INC.
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DESCRIPTION
CLINICAL PHARMACOLOGY
INDICATIONS & USAGE
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
LABORATORY TESTS
DRUG INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
NURSING MOTHERS
PEDIATRIC USE
ADVERSE REACTIONS
OVERDOSAGE
DOSAGE & ADMINISTRATION
HOW SUPPLIED
REFERENCES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
SEROMYCIN
cycloserine capsule
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
Item Code (Source)
NDC:49349-018
Route of Administration
ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
CYCLOSERINE
(UNII: 95IK5KI84Z) (CYCLOSERINE - UNII:95IK5KI84Z)
CYCLOSERINE
250 mg
Inactive Ingredients
Ingredient Name
Strength
D&C YELLOW NO. 10
(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1
(UNII: H3R47K3TBD)
FD&C RED NO. 3
(UNII: PN2ZH5LOQY)
FD&C YELLOW NO. 6
(UNII: H77VEI93A8)
GELATIN
(UNII: 2G86QN327L)
TALC
(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE
(UNII: 15FIX9V2JP)
Product Characteristics
Color
red, gray
Score
2 pieces
Shape
CAPSULE (CAPSULE)
Size
20mm
Flavor
Imprint Code
LILLY;F04
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:49349-018-02
30 in 1 BLISTER PACK; Type 0: Not a Combination Product
08/02/2011
08/02/2011
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
ANDA
ANDA060593
08/02/2011
08/02/2011
Labeler -
REMEDYREPACK INC. (829572556)
Revised: 7/2016
Document Id:
36ea6ded-ace5-2f30-e054-00144ff88e88
Set id: 59cb6358-a75a-433b-ae13-4343797ca7d9
Version: 53
Effective Time: 20160705
REMEDYREPACK INC.