Application 206699

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PARICALCITOL	PARICALCITOL	SOLUTION;INTRAVENOUS	0.002MG/ML (0.002MG/ML)	No	No
002	PARICALCITOL	PARICALCITOL	SOLUTION;INTRAVENOUS	0.005MG/ML (0.005MG/ML)	No	No
003	PARICALCITOL	PARICALCITOL	SOLUTION;INTRAVENOUS	0.01MG/2ML (0.005MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206699-001	PARICALCITOL	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09
A206699-002	PARICALCITOL	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09
A206699-003	PARICALCITOL	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A206699-001	AP
A206699-002	AP
A206699-003	AP

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 1 of 4 · 126 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
2026-08-18 06:07:40	2026-07	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206699-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206699-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206699-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206699-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206699-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206699-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206699-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206699-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206699-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206699-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206699-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206699-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206699-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206699-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206699-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206699-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206699-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206699-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206699-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206699-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206699-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206699-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206699-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206699-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206699-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206699-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206699-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206699-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206699-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206699-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206699-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206699-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206699-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206699-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206699-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206699-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206699-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206699-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206699-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206699-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206699-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206699-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206699-001	AP	1	`1e350fbaab3a…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paricalcitol	PARICALCITOL	Amneal Pharmaceuticals LLC	8e0b016c-4bda-487e-b525-63abfb772761	2024-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206699 application number: ANDA206699 ndc (product): 70121-1035 ndc (product): 70121-1033 ndc (product): 70121-1036 ndc (product): 70121-1034

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70121-1033	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1033	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1033	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1033	Paricalcitol	Paricalcitol	Amneal Biosciences LLC	ANDA	Current
70121-1034	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1034	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1034	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1034	Paricalcitol	Paricalcitol	Amneal Biosciences LLC	ANDA	Current
70121-1035	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1035	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1035	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1035	Paricalcitol	Paricalcitol	Amneal Biosciences LLC	ANDA	Current
70121-1036	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1036	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1036	Paricalcitol	Paricalcitol	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1036	Paricalcitol	Paricalcitol	Amneal Biosciences LLC	ANDA	Current