Application 202168

Type: ANDA
Sponsor: CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	400MG	No	No
002	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	800MG	No	No

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

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
A202168-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-11-15
A202168-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		2013-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202168-001	AB
A202168-002	AB

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 3 · 84 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	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202168-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2013-11-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202168-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2013-11-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A202168-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202168-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202168-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202168-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202168-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202168-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202168-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202168-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202168-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202168-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202168-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202168-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202168-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202168-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202168-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202168-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202168-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202168-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202168-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202168-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202168-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202168-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202168-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202168-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202168-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202168-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202168-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202168-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202168-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202168-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202168-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202168-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202168-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202168-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202168-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202168-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202168-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202168-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202168-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202168-002	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Cadila Pharmaceuticals Limited	acef88f4-6456-4092-993f-27e1496097c7	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202168 application number: ANDA202168 ndc (product): 71209-006 ndc (product): 71209-005
Acyclovir	ACYCLOVIR	Modavar Pharmaceuticals LLC	8de9c4f3-b800-4419-a063-8b62a0cba0fa	2022-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202168 application number: ANDA202168 ndc (product): 72241-027 ndc (product): 72241-026

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53002-0080	Acyclovir	Acyclovir	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-0080	Acyclovir	Acyclovir	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-0081	Acyclovir	Acyclovir	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-0081	Acyclovir	Acyclovir	RPK Pharmaceuticals, Inc.	ANDA	Current
67296-1625	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
67296-1625	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
68071-4345	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
71209-005	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71209-005	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71209-005	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71209-005	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71209-006	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71209-006	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71209-006	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71209-006	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
72241-026	Acyclovir	Acyclovir	Modavar Pharmaceuticals LLC	ANDA	Current
72241-026	Acyclovir	Acyclovir	Modavar Pharmaceuticals LLC	ANDA	Current
72241-027	Acyclovir	Acyclovir	Modavar Pharmaceuticals LLC	ANDA	Current
72241-027	Acyclovir	Acyclovir	Modavar Pharmaceuticals LLC	ANDA	Current
75834-122	Acyclovir	Acyclovir	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-122	Acyclovir	Acyclovir	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-122	Acyclovir	Acyclovir	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-123	Acyclovir	Acyclovir	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-123	Acyclovir	Acyclovir	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-123	Acyclovir	Acyclovir	Nivagen Pharmaceuticals, Inc.	ANDA	Current