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
(click image for full-size original)

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.

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