Vitamin A Palmitate
Drug - Vitamin A Palmitate
The trade name of the product as shown on the labeling.
Dosage -
CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Vitamin A Palmitate
Multiple ingredients are in alphabetical order.
Strength -
EQ 50,000 UNITS BASE
The potency of the active ingredient(s), Vitamin A Palmitate. May repeat for multiple part products.
Applicant -
ARCUM
The firm name holding legal responsibility for Vitamin A Palmitate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
083321
The FDA assigned number to Vitamin A Palmitate. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Vitamin A Palmitate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AA
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Approved Prior to Jan 1, 1982
The date Vitamin A Palmitate 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) -
No
The pioneer or innovator of Vitamin A Palmitate. 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 Vitamin A Palmitate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Arcum Pharmaceutical Corp
The full name of the firm holding legal responsibility for the new application of Vitamin A Palmitate.
Vitamin A Palmitate
Vitamin A Eq 25,000 Units Base Capsule; Oral Vitamin A Eq 50,000 Units Base Capsule; Oral Vitamin A Eq 50,000 Units Base Capsule; Oral Vitamin A Eq 50,000 Units Base Capsule; Oral Vitamin A Palmitate Eq 50,000 Units Base Capsule; Oral Vitamin A Palmitate Eq 50,000 Units Base Capsule; Oral Vitamin A Eq 50,000 Units Base Capsule; Oral Vitamin A Eq 50,000 Units Base Capsule; Oral Vitamin A Eq 50,000 Units Base Capsule; Oral Vitamin A Eq 50,000 Units Base Capsule; Oral
NewDrugInformation
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