ber or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050480 09/23/1974
VIBRAMYCIN HYCLATE
doxycycline hyclate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0069-0950
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code Vibra;Pfizer;095
Contains
Packaging
# Item Code Package Description
1 NDC:0069-0950-50 50 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050007 12/05/1967
VIBRA-TABS
doxycycline hyclate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0069-0990
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSES
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
ALUMINUM OXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code Vibra;Pfizer;099
Contains
Packaging
# Item Code Package Description
1 NDC:0069-0990-50 50 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050533 01/15/1980
Labeler - Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Business Operations
Pfizer Ireland Pharmaceuticals 896090987 API MANUFACTURE(0069-0990, 0069-0950, 0069-0971, 0069-0970)
Establishment
Name Address ID/FEI Business Operations
Patheon Puerto Rico, Inc 143814544 ANALYSIS(0069-0970), LABEL(0069-0970), MANUFACTURE(0069-0970), PACK(0069-0970)
Establishment
Name Address ID/FEI Business Operations
Pfizer Laboratories Div Pfizer Inc 001147495 ANALYSIS(0069-0990, 0069-0950, 0069-0971, 0069-0970), API MANUFACTURE(0069-0990, 0069-0950, 0069-0971, 0069-0970)
Establishment
Name Address ID/FEI Business Operations
Pharmacia and Upjohn Company 829076566 ANALYSIS(0069-0971), LABEL(0069-0971), MANUFACTURE(0069-0971), PACK(006 |
