Application 075393

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	INJECTABLE;INJECTION	EQ 50MG BASE/ML	No	No
002	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	INJECTABLE;INJECTION	EQ 100MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075393-001	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION			1999-05-11
A075393-002	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION			1999-05-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1999-05-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION		1999-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1999-05-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION		1999-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075393-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075393-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	1999-05-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075393-001	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075393-002	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075393-001	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075393-002	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075393-001	AO	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075393-002	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075393-001	AO	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075393-002	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075393-001	AO	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075393-002	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075393-001	AO	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075393-002	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075393-001	AO	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075393-002	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075393-001	AO	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075393-002	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075393-001	AO	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075393-002	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075393-001	AO	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075393-002	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075393-001	AO	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075393-002	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075393-001	AO	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075393-002	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075393-001	AO	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075393-002	AO	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A075393-001	AO	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075393-002	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075393-001	AO	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075393-002	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075393-001	AO	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075393-002	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075393-001	AO	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075393-002	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075393-001	AO	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075393-002	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075393-001	AO	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075393-002	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075393-001	AO	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075393-002	AO	1	`3bdfa0b2c4d7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol Decanoate	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	2cdd9fca-afe5-4bfa-8db1-337beec13c6b	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Gland Pharma Limited	1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol decanoate	HALOPERIDOL DECANOATE	Zydus Pharmaceuticals USA Inc.	6d2d7612-ad47-4ee7-a42c-945c976d947b	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	NorthStar RxLLC	b83cb022-cfeb-4492-927b-0b461f7201d4	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Lifestar Pharma LLC	8a96195e-97cd-4161-96e0-494a1636fa9c	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	4a3653df-84c7-46c2-b8fd-28c63cd2747a	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Armas Pharmaceuticals Inc.	80d51d2c-30e4-4eef-b184-0cebb30ca429	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Armas Pharmaceuticals Inc.	9979e28f-2716-4788-8605-16f6edf158b5	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Meitheal Pharmaceuticals Inc.	14f40303-9604-4a30-8e86-8abaeb177ce1	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	15b82169-882b-40ef-bbda-5adc3e7eb930	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Mylan Institutional LLC	8ffac6fb-1702-40d6-b085-152d24673cbd	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	068fc913-779d-44c6-9585-3aa80e751bee	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL DECANOATE generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Caplin Steriles Limited	4f9af14a-38c4-4826-aca0-3501edb854e3	2025-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Armas Pharmaceuticals Inc.	f9876b88-3caa-4c08-9a59-9b4a455e101d	2025-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Patriot Pharmaceuticals LLC	9f0f42a8-5f7c-4be7-93ef-3ec225502cc6	2025-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Hikma Pharmaceuticals USA Inc.	914026da-103a-4466-abd5-3763e9d55b67	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol Decanoate generic name: HALOPERIDOL DECANOATE
haloperidol decanoate	HALOPERIDOL DECANOATE	Sagent Pharmaceuticals	b3167043-585f-482f-b8a7-591bc2721bd3	2024-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: haloperidol decanoate generic name: HALOPERIDOL DECANOATE
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	f2bff27f-929f-4f7d-b3eb-084ebc2a885f	2023-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL DECANOATE generic name: HALOPERIDOL DECANOATE
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	BluePoint Laboratories	f2d14406-2ad4-4c5b-9c24-a026f27b415d	2023-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL DECANOATE generic name: HALOPERIDOL DECANOATE
Haloperidol decanoate	HALOPERIDOL DECANOATE	Zydus Lifesciences Limited	d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9	2023-09-01		Name fallback brand name: Haloperidol decanoate generic name: HALOPERIDOL DECANOATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-7011	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7011	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7011	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7011	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7011	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7013	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7013	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7013	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7013	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7013	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7021	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7021	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7021	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7021	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7021	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7023	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7023	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7023	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7023	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7023	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7121	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7121	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7121	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7123	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7123	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7123	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7131	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7131	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7131	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7133	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7133	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-7133	Haloperidol Decanoate	Haloperidol Decanoate	Teva Parenteral Medicines, Inc.	ANDA	Current
70518-3097	Haloperidol Decanoate	Haloperidol Decanoate	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42990	ORIG	1999-05-11
8645	ORIG	1999-05-11