Amantadine Hydrochloride (Page 5 of 5)

HOW SUPPLIED

Amantadine Hydrochloride Oral Solution USP, 50 mg/5 mL is a colorless to pale yellow, raspberry-flavored oral solution available in:

1 Pint (473 mL) bottles NDC 60432-093-16

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

KEEP TIGHTLY CLOSED

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Rx Only

REFERENCES

¹ W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can. Med. Assoc. J. 129:974–975, 1983.

² D.F. Casey, N. Engl. J. Med. 298:516, 1978.

³ C.D. Berkowitz, J. Pediatr. 95:144, 1979.

Product No.: 8093

Manufactured for:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

A50-8093-16

REV. 07-18

PRINCIPAL DISPLAY PANEL mL Bottle Label

MGP

NDC 60432-093-16

Amantadine

Hydrochloride

Oral Solution, USP

50 mg/5 mL

DO NOT USE IF TAMPER-EVIDENT SEAL

IS BROKEN OR MISSING.

Rx Only

NET: 1 Pint (473 mL)

Amantadine Hydrochloride Oral Solution Label

AMANTADINE HYDROCHLORIDE amantadine hydrochloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-093 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMANTADINE HYDROCHLORIDE (AMANTADINE) AMANTADINE HYDROCHLORIDE 50 mg in 5 mL

Inactive Ingredients Ingredient Name Strength WATER SORBITOL PROPYLENE GLYCOL TRISODIUM CITRATE DIHYDRATE SACCHARIN SODIUM METHYLPARABEN PROPYLPARABEN ANHYDROUS CITRIC ACID

Product Characteristics Color Score Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60432-093-16 473 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075060 12/24/1998

Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)

Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)

Establishment
Name	Address	ID/FEI	Operations
Morton Grove Pharmaceuticals, Inc.		801897505	ANALYSIS (60432-093), LABEL (60432-093), MANUFACTURE (60432-093), PACK (60432-093)

Establishment
Name	Address	ID/FEI	Operations
Moehs Catalana S.L.		460021629	API MANUFACTURE (60432-093)

Revised: 12/2018 Morton Grove Pharmaceuticals, Inc.