Ogestrel 0.5/50-21
Drug - Ogestrel 0.5/50-21
The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL-21
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Ethinyl Estradiol; Norgestrel
Multiple ingredients are in alphabetical order.
Strength -
0.05MG;0.5MG
The potency of the active ingredient(s), Ethinyl Estradiol; Norgestrel. May repeat for multiple part products.
Applicant -
WATSON LABS
The firm name holding legal responsibility for Ogestrel 0.5/50-21. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
075406
The FDA assigned number to Ogestrel 0.5/50-21. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Ogestrel 0.5/50-21. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Dec 15, 1999
The date Ogestrel 0.5/50-21 was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".
Reference Listed Drug (RLD) -
Yes
The pioneer or innovator of Ogestrel 0.5/50-21. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
RX
The group or category of approved drugs Ogestrel 0.5/50-21 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Watson Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Ogestrel 0.5/50-21.
Ogestrel 0.5/50-21
Previfem 0.035mg;0.25mg Tablet; Oral-28 Sprintec 0.035mg;0.25mg Tablet; Oral-28 Tri-previfem 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg Tablet; Oral-28 Tri-sprintec 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg Tablet; Oral-28 Cryselle 0.03mg;0.3mg Tablet; Oral-21 Lo/ovral 0.03mg;0.3mg Tablet; Oral-21 Low-ogestrel-21 0.03mg;0.3mg Tablet; Oral-21 Ogestrel 0.5/50-21 0.05mg;0.5mg Tablet; Oral-21 Ortho Tri-cyclen 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg Tablet; Oral-28 Ortho Tri-cyclen Lo 0.025mg,0.025mg,0.25mg;0.18mg,0.215mg,0.25mg Tablet; Oral-28
NewDrugInformation
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