Aquasol A
Drug - Aquasol A
The trade name of the product as shown on the labeling.
Dosage -
INJECTABLE; INJECTION
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/ML
The potency of the active ingredient(s), Vitamin A Palmitate. May repeat for multiple part products.
Applicant -
MAYNE PHARMA USA
The firm name holding legal responsibility for Aquasol A. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
006823
The FDA assigned number to Aquasol A. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Aquasol A. 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 -
Approved Prior to Jan 1, 1982
The date Aquasol A 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 Aquasol A. 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 Aquasol A is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Mayne Pharma Usa Inc
The full name of the firm holding legal responsibility for the new application of Aquasol A.
Aquasol A
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 Palmitate Eq 50,000 Units Base Capsule; Oral Vitamin A Palmitate Eq 50,000 Units Base Capsule; Oral Vitamin A Solubilized Eq 50,000 Units Base Capsule; Oral Aquasol A Eq 50,000 Units Base/ml Injectable; Injection
NewDrugInformation
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