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Approved Drug Products of Bausch Health listed in the FDA Orange Book. Original Data : FDA Website

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01 ACETAMINOPHEN; BUTALBITAL (2)

02 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE (1)

03 ACETAMINOPHEN; CODEINE PHOSPHATE (2)

04 AMINOPHYLLINE (1)

05 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE (1)

06 BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE (1)

07 BALSALAZIDE DISODIUM (2)

08 BENZOYL PEROXIDE; ERYTHROMYCIN (1)

09 BEXAROTENE (1)

10 BRODALUMAB (1)

11 CARBIDOPA (1)

12 CHLORDIAZEPOXIDE (4)

13 CHLORDIAZEPOXIDE HYDROCHLORIDE (5)

14 CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX (2)

15 CICLOPIROX (1)

16 DICLOFENAC SODIUM (1)

17 DILTIAZEM HYDROCHLORIDE (18)

18 DILTIAZEM MALATE; ENALAPRIL MALEATE (1)

19 DIPHENHYDRAMINE HYDROCHLORIDE (2)

20 ERYTHROMYCIN (1)

21 FENOFIBRATE (2)

22 FLUOROURACIL (1)

23 FLUOXYMESTERONE (2)

24 FLURAZEPAM HYDROCHLORIDE (2)

25 FOLIC ACID (1)

26 GATIFLOXACIN (1)

27 GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE (1)

28 GRISEOFULVIN, MICROCRYSTALLINE (2)

29 GRISEOFULVIN, MICROSIZE (2)

30 HYDROCORTISONE (9)

31 ISONIAZID (1)

32 ISOSORBIDE DINITRATE (3)

33 LEVODOPA (3)

34 LEVORPHANOL TARTRATE (2)

35 MEPROBAMATE (2)

36 METHOXSALEN (2)

37 METHYLTESTOSTERONE (3)

38 MINOCYCLINE HYDROCHLORIDE (1)

39 MONOBENZONE (1)

40 NIFEDIPINE (5)

41 NITROGLYCERIN (3)

42 PENICILLAMINE (2)

43 PENTOBARBITAL SODIUM (1)

44 PENTOXIFYLLINE (1)

45 PERGOLIDE MESYLATE (3)

46 PHENDIMETRAZINE TARTRATE (2)

47 PIPERACETAZINE (2)

48 PREDNICARBATE (2)

49 PREDNISOLONE (1)

50 PREDNISONE (1)

51 PRIMIDONE (2)

52 PROPOXYPHENE HYDROCHLORIDE (1)

53 QUINIDINE SULFATE (1)

54 RAUWOLFIA SERPENTINA ROOT (2)

55 RESERPINE (2)

56 SECOBARBITAL SODIUM (3)

57 SODIUM NITROPRUSSIDE (1)

58 SULFISOXAZOLE (1)

59 TETRACYCLINE HYDROCHLORIDE (2)

60 THEOPHYLLINE (2)

61 TRAMADOL HYDROCHLORIDE (3)

62 TRETINOIN (10)

63 TRIOXSALEN (1)

64 VENLAFAXINE HYDROCHLORIDE (3)

65 VERTEPORFIN (1)

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01 CAPSULE, EXTENDED RELEASE;ORAL (24)

02 CAPSULE;ORAL (26)

03 CREAM;TOPICAL (11)

04 FILM, EXTENDED RELEASE;TRANSDERMAL (3)

05 GEL;TOPICAL (4)

06 INJECTABLE;INJECTION (5)

07 LOTION;TOPICAL (7)

08 OINTMENT;OPHTHALMIC (1)

09 OINTMENT;TOPICAL (1)

10 POWDER, EXTENDED RELEASE;DENTAL (1)

11 SOLUTION/DROPS;OPHTHALMIC (1)

12 SOLUTION; OPHTHALMIC (1)

13 SOLUTION;TOPICAL (3)

14 SUSPENSION;ORAL (2)

15 SWAB;TOPICAL (1)

16 TABLET, EXTENDED RELEASE;ORAL (11)

17 TABLET;BUCCAL (1)

18 TABLET;ORAL (42)

19 TABLET;SUBLINGUAL (3)

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01 0.01% (1)

02 0.02% (1)

03 0.025% (1)

04 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML (1)

05 0.025MG;2.5MG (1)

06 0.05% (5)

07 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

08 0.1% (1)

09 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (2)

10 0.1MG (1)

11 0.1MG/HR (1)

12 0.25MG (1)

13 0.2MG/HR (1)

14 0.3% (1)

15 0.5% (2)

16 0.6MG/HR (1)

17 1% (3)

18 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (2)

19 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

20 100MG (6)

21 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

22 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

23 105MG (1)

24 10MG (7)

25 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (2)

26 120MG (3)

27 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

28 120MG/5ML;12MG/5ML (1)

29 125MG (3)

30 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

31 145MG (1)

32 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

33 15MG/VIAL (1)

34 180MG (2)

35 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

36 1MG (1)

37 2% (1)

38 2.5% (2)

39 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (2)

40 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

41 20% (1)

42 200MG (3)

43 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

44 210MG/1.5ML (1)

45 240MG (2)

46 250MG (5)

47 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

48 25MG (5)

49 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

50 25MG/ML (1)

51 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

52 2MG/ML (1)

53 300MG (3)

54 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

55 300MG;30MG (1)

56 30MG (3)

57 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

58 325MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

59 325MG;50MG;40MG;30MG (1)

60 35MG (1)

61 360MG (1)

62 400MG (2)

63 420MG (1)

64 48MG (1)

65 5%;3% (1)

66 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM (1)

67 500MG (4)

68 50MG (4)

69 5MG (6)

70 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (2)

71 60MG (3)

72 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

73 650MG;50MG (1)

74 65MG (1)

75 750MG (1)

76 75MG (1)

77 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

78 90MG (2)

79 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

80 EQ 0.05MG BASE (1)

81 EQ 0.25MG BASE (1)

82 EQ 150MG BASE (1)

83 EQ 180MG HYDROCHLORIDE;5MG (1)

84 EQ 1MG BASE (2)

85 EQ 37.5MG BASE (1)

86 EQ 4MG MALEATE;EQ 5MG BITARTRATE (1)

87 EQ 75MG BASE (1)

88 EQ 8MG MALEATE;EQ 10MG BITARTRATE (1)

filter

01 DISCN (109)

02 RX (37)

03 Blank (2)

URL Supplier Web Content
TABLET; ORAL
325MG;50MG **Feder...
1985-06-19
87811
PHRENILIN
DISCN
Yes
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CAPSULE; ORAL
650MG;50MG
1985-06-19
88831
PHRENILIN FORTE
DISCN
No
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CAPSULE; ORAL
325MG;50MG;40MG;30...
2001-08-22
74911
PHRENILIN WITH CAF...
DISCN
No
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TABLET; ORAL
300MG;30MG
1982-01-01
85896
ACETAMINOPHEN AND ...
DISCN
No
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SUSPENSION; ORAL
120MG/5ML;12MG/5ML
1982-01-01
86024
CAPITAL AND CODEIN...
DISCN
No
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TABLET; ORAL
200MG
1982-01-01
84563
AMINOPHYLLINE
DISCN
No
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TABLET; ORAL
0.025MG;2.5MG
1982-02-16
87195
DIPHENOXYLATE HYDR...
DISCN
No
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OINTMENT; OPHTHALM...
500 UNITS/GM;EQ 3....
1982-01-01
60647
NEO-POLYCIN
DISCN
No
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CAPSULE; ORAL
750MG
2000-07-18
20610
COLAZAL
RX
Yes
AB
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TABLET; ORAL
1.1GM **Federal Re...
2012-02-03
22205
GIAZO
DISCN
Yes
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